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Laguna, F. Suárez-Sipmann, G. Tusman, J. Ripollés, O. Díaz-Cambronero, R. Pujol, E. Rivas, I. Garutti, R. Mellado, J. Vallverdú, A. Jacas, A. Fervienza, R. Marrero, J. Librero, J. Villar, C. Ferrando" "autores" => array:16 [ 0 => array:2 [ "nombre" => "G." "apellidos" => "Laguna" ] 1 => array:2 [ "nombre" => "F." "apellidos" => "Suárez-Sipmann" ] 2 => array:2 [ "nombre" => "G." "apellidos" => "Tusman" ] 3 => array:2 [ "nombre" => "J." "apellidos" => "Ripollés" ] 4 => array:2 [ "nombre" => "O." "apellidos" => "Díaz-Cambronero" ] 5 => array:2 [ "nombre" => "R." "apellidos" => "Pujol" ] 6 => array:2 [ "nombre" => "E." "apellidos" => "Rivas" ] 7 => array:2 [ "nombre" => "I." "apellidos" => "Garutti" ] 8 => array:2 [ "nombre" => "R." "apellidos" => "Mellado" ] 9 => array:2 [ "nombre" => "J." "apellidos" => "Vallverdú" ] 10 => array:2 [ "nombre" => "A." "apellidos" => "Jacas" ] 11 => array:2 [ "nombre" => "A." "apellidos" => "Fervienza" ] 12 => array:2 [ "nombre" => "R." 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"apellidos" => "Ferrando" ] ] ] ] ] "idiomaDefecto" => "es" "Traduccion" => array:1 [ "en" => array:9 [ "pii" => "S2341192924000751" "doi" => "10.1016/j.redare.2024.04.007" "estado" => "S300" "subdocumento" => "" "abierto" => array:3 [ "ES" => false "ES2" => false "LATM" => false ] "gratuito" => false "lecturas" => array:1 [ "total" => 0 ] "idiomaDefecto" => "en" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2341192924000751?idApp=UINPBA00004N" ] ] "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S0034935624000082?idApp=UINPBA00004N" "url" => "/00349356/0000007100000006/v1_202405290553/S0034935624000082/v1_202405290553/es/main.assets" ] ] "itemSiguiente" => array:19 [ "pii" => "S2341192924000830" "issn" => "23411929" "doi" => "10.1016/j.redare.2024.04.015" "estado" => "S300" "fechaPublicacion" => "2024-06-01" "aid" => "1598" "copyright" => "Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor" "documento" => "article" "crossmark" => 1 "subdocumento" => "fla" "cita" => "Revista Española de Anestesiología y Reanimación (English Version). 2024;71:454-65" "abierto" => array:3 [ "ES" => false "ES2" => false "LATM" => false ] "gratuito" => false "lecturas" => array:1 [ "total" => 0 ] "en" => array:12 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Special article</span>" "titulo" => "Management of peri-surgical anemia in elective surgery. 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Laguna, F. Suárez-Sipmann, G. Tusman, J. Ripollés, O. Díaz-Cambronero, R. Pujol, E. Rivas, I. Garutti, R. Mellado, J. Vallverdú, A. Jacas, A. Fervienza, R. Marrero, J. Librero, J. Villar, C. Ferrando" "autores" => array:16 [ 0 => array:4 [ "nombre" => "G." "apellidos" => "Laguna" "email" => array:1 [ 0 => "gjlaguna@clinic.cat" ] "referencia" => array:2 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">*</span>" "identificador" => "cor0005" ] ] ] 1 => array:3 [ "nombre" => "F." "apellidos" => "Suárez-Sipmann" "referencia" => array:2 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">c</span>" "identificador" => "aff0015" ] ] ] 2 => array:3 [ "nombre" => "G." "apellidos" => "Tusman" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">d</span>" "identificador" => "aff0020" ] ] ] 3 => array:3 [ "nombre" => "J." "apellidos" => "Ripollés" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">e</span>" "identificador" => "aff0025" ] ] ] 4 => array:3 [ "nombre" => "O." "apellidos" => "Díaz-Cambronero" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">f</span>" "identificador" => "aff0030" ] ] ] 5 => array:3 [ "nombre" => "R." "apellidos" => "Pujol" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] ] ] 6 => array:3 [ "nombre" => "E." "apellidos" => "Rivas" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] ] ] 7 => array:3 [ "nombre" => "I." "apellidos" => "Garutti" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">g</span>" "identificador" => "aff0035" ] ] ] 8 => array:3 [ "nombre" => "R." "apellidos" => "Mellado" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] ] ] 9 => array:3 [ "nombre" => "J." "apellidos" => "Vallverdú" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] ] ] 10 => array:3 [ "nombre" => "A." "apellidos" => "Jacas" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] ] ] 11 => array:3 [ "nombre" => "A." "apellidos" => "Fervienza" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] ] ] 12 => array:3 [ "nombre" => "R." "apellidos" => "Marrero" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] ] ] 13 => array:3 [ "nombre" => "J." "apellidos" => "Librero" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">h</span>" "identificador" => "aff0040" ] ] ] 14 => array:3 [ "nombre" => "J." "apellidos" => "Villar" "referencia" => array:2 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">c</span>" "identificador" => "aff0015" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">i</span>" "identificador" => "aff0045" ] ] ] 15 => array:3 [ "nombre" => "C." "apellidos" => "Ferrando" "referencia" => array:2 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">c</span>" "identificador" => "aff0015" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">j</span>" "identificador" => "aff0050" ] ] ] ] "afiliaciones" => array:10 [ 0 => array:3 [ "entidad" => "Departamento de Anestesia y Cuidados Críticos, Hospital Clínic, Barcelona, España" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Unidad de Cuidados Intensivos, Hospital Universitario La Princesa, Madrid, España" "etiqueta" => "b" "identificador" => "aff0010" ] 2 => array:3 [ "entidad" => "CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, España" "etiqueta" => "c" "identificador" => "aff0015" ] 3 => array:3 [ "entidad" => "Departamento de Anestesia, Hospital Privado de Comunidad, Mar de Plata, Argentina" "etiqueta" => "d" "identificador" => "aff0020" ] 4 => array:3 [ "entidad" => "Departamento de Anestesia, Hospital Infanta Leonor, Madrid, España" "etiqueta" => "e" "identificador" => "aff0025" ] 5 => array:3 [ "entidad" => "Departamento de Anestesia, Hospital La Fe, Valencia, España" "etiqueta" => "f" "identificador" => "aff0030" ] 6 => array:3 [ "entidad" => "Departamento de Anestesia, Hospital Universitario Gregorio Marañón, Madrid, España" "etiqueta" => "g" "identificador" => "aff0035" ] 7 => array:3 [ "entidad" => "Navarrabiomed-Fundación Miguel Servet, Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Pamplona, España" "etiqueta" => "h" "identificador" => "aff0040" ] 8 => array:3 [ "entidad" => "Red Multidisciplinar de Investigación en Evaluación de Disfunción de Órganos, Unidad de Investigación, Hospital Universitario Dr. Negrín, Las Palmas de Gran Canaria, España" "etiqueta" => "i" "identificador" => "aff0045" ] 9 => array:3 [ "entidad" => "Departamento de Anestesia y Cuidados Críticos, Hospital Clínic, Institut D’Investigació August Pi i Sunyer, Barcelona, España" "etiqueta" => "j" "identificador" => "aff0050" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Fundamento y diseño del estudio para una estrategia ventilatoria con pulmón abierto perioperatoria individualizada en laparotomía/laparoscopia abdominal urgente (iPROVE): protocolo del estudio para ensayo controlado aleatorizado prospectivo internacional" ] ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:8 [ "identificador" => "fig0010" "etiqueta" => "Figure 2" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr2.jpeg" "Alto" => 3023 "Ancho" => 2091 "Tamanyo" => 814994 ] ] "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0010" "detalle" => "Figure " "rol" => "short" ] ] "descripcion" => array:1 [ "en" => "<p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Protocolized perioperative ventilatory management.</p>" ] ] ] "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0055">Background</span><p id="par0005" class="elsevierStylePara elsevierViewall">Postoperative pulmonary complications (PPCs) are the most frequent postoperative complications, and have a significant impact on morbidity, mortality, and consumption of health system resources.<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1–3</span></a> Recent studies have described perioperative PPC factors and prediction models that can be used to establish prevention strategies,<a class="elsevierStyleCrossRefs" href="#bib0020"><span class="elsevierStyleSup">4,5</span></a> and several clinical studies have compared different lung-protective strategies that can prevent these complications.<a class="elsevierStyleCrossRefs" href="#bib0030"><span class="elsevierStyleSup">6–9</span></a> One of the most widely studied populations are patients undergoing scheduled abdominal surgery. The prevalence of PPCs in this population ranges from 20% in observational cohort studies to 40% in randomized clinical trials (RCT).<a class="elsevierStyleCrossRefs" href="#bib0035"><span class="elsevierStyleSup">7–9</span></a> However, the prevalence of PPCs in patients undergoing emergency abdominal surgery is not well defined. Studies such as ARISCAT or LAS VEGAS have shown that emergency abdominal surgery is an independent risk factor for PPCs.<a class="elsevierStyleCrossRefs" href="#bib0020"><span class="elsevierStyleSup">4,5</span></a> Recently, Watson et al. reported a prevalence of 48% in patients included in the British national audit of emergency laparotomy (NELA).<a class="elsevierStyleCrossRefs" href="#bib0050"><span class="elsevierStyleSup">10,11</span></a> Extrapolating these data to Spain, where approximately 140,000 emergency abdominal surgeries are performed per year,<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">12</span></a> suggests that 70,000 patients per year will suffer at least one PPC. With an average cost of €2,800 per lung complication, the impact on the public health system would be close to €200 million/year.<a class="elsevierStyleCrossRefs" href="#bib0065"><span class="elsevierStyleSup">13,14</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">No further data on the real prevalence and risk factors of PPCs have been published, and no further RCTs have analysed ventilatory strategies to reduce PPCs in this population. Watson et al. showed that lung-protective ventilation, defined by the authors as a combination of low tidal volume (V<span class="elsevierStyleInf">T</span>) recruitment manoeuvres (RM) and positive end-expiratory pressure (PEEP) >5 cmH<span class="elsevierStyleInf">2</span>O, is applied in less than 5% of patients, and that patients ventilated with high peak pressures and fraction of inspired oxygen (FiO<span class="elsevierStyleInf">2</span>) are more likely to develop a PPC.<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a> However, other variables that have shown an association with PPCs, such as plateau pressure (Pplat) or driving pressure (DP), were not reported.<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">15</span></a> In contrast to various RCTs and meta-analyses that found RM and PEEP to have a protective effect,<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1,8–9,16</span></a> Watson et al. did not observe any correlation between these variables and PPCs, although RMs were performed in only 9.5% of patients and the study did not specify how PEEP was adjusted.</p><p id="par0015" class="elsevierStylePara elsevierViewall">Lung-protective ventilation aims to minimize both ventilation-induced lung injury - by avoiding tidal overdistension secondary to the use of high volumes or pressures - and atelectrauma produced by repetitive alveolar opening and closure. The open lung approach (OLA), which until now has been defined as RM to open up collapsed alveoli followed by PEEP titrated to a level that will prevent re-collapse, aims to homogenize the lung and reduce the risk of lung injury and PPCs. On this basis, we hypothesized that applying an individualized ventilatory strategy based on real-time monitoring and individualised intraoperative RMs and PEEP to maintain alveolar recruitment during the immediate intraoperative and postoperative, combined with postoperative ventilatory support (PVS) in case of alveolar re-collapse will reduce the risk of PPCs in patients presenting alveolar collapse, which can be accurately predicted with pulse-oximetry in surgical patients.<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">17</span></a> We will, therefore, perform a study to compare this individualized, monitored perioperative open lung ventilation strategy with conventional standardized lung-protective ventilation in patients undergoing emergency abdominal surgery with clinical signs of lung collapse.</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0060">Methods</span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0065">Study design</span><p id="par0020" class="elsevierStylePara elsevierViewall">Prospective, international, controlled, clinical trial, stratified by centre, in which patients will be randomised to 2 parallel ventilatory management groups (<a class="elsevierStyleCrossRef" href="#fig0005">Fig. 1</a>). The trial has been designed in accordance with the fundamental principles of the Declaration of Helsinki, the Convention of the European Council relating to human rights and biomedicine, and the Universal Declaration of UNESCO on the human genome and human rights, and complies with Spanish regulations governing biomedical research, the protection of personal data, and bioethics. The study was classified by the Spanish Agency of Medicines and Medical Devices as a randomized clinical study without drugs, and has been registered at <a href="http://www.clinicaltrials.gov">http://www.clinicaltrials.gov</a> (NCT04229810). The final protocol will need to be approved by the local ethics committee of each participating hospital before patient enrolment. The study will be reported in accordance with the Standard Protocol Items: CONSORT 2010 Statement: updated guidelines for reporting parallel group randomized trials.<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">18</span></a></p><elsevierMultimedia ident="fig0005"></elsevierMultimedia></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Participants</span><p id="par0025" class="elsevierStylePara elsevierViewall">Patients who meet all the following inclusion criteria: (i) adult men and women (≥18 years of age), (ii) undergoing emergency abdominal surgery, (iii) with a positive post-induction air test (SpO<span class="elsevierStyleInf">2</span> <97% after a maximum of 5 min at FiO<span class="elsevierStyleInf">2</span> 0.21) or SpO<span class="elsevierStyleInf">2</span> <97% at any FiO<span class="elsevierStyleInf">2</span> as a reliable clinical sign of lung collapse,<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">17</span></a> and none of the following exclusion criteria: (i) pregnancy or breast feeding, (ii) moderate or severe ARDS, (iii) refractory shock, (iv) diagnosed or suspected intracranial hypertension (>15 mmHg), (v) MV in the preceding 15 days (including CPAP), (vi) presence of pneumothorax or giant bullae on chest radiograph or computed tomography (CT), (vii) participating in another interventional study with similar primary outcome variable, will be included in the study.</p><p id="par0030" class="elsevierStylePara elsevierViewall">If a patient is not able to sign the informed consent form before entering the trial due to a vital emergency or poor clinical condition, we will act in accordance with current legislation and informed consent will not be obtained, will be signed by a relative or representative, or will be obtained a posteriori, provided that the conditions listed in article 35, sections 1 and 2 of Regulation (EU) No. 536/2014 of the European Parliament and Council, of April 16, 2014 and in Article 7 of Royal Decree 1090/2015, of December 4 on Clinical trials in emergency situations have been met; in this case, family members or other persons close to the subject will be consulted. This possibility and the procedure to be followed must be provided for in the trial documentation approved by the Ethics Committee, and the person or their legally designated representative will be informed as soon as possible and must give their consent to enter or continue in the trial, as appropriate. If the trial subject or, as applicable, their legally designated representative cannot give consent, they will be informed of their right to object to the use of the data obtained from the trial.</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Interventions</span><p id="par0035" class="elsevierStylePara elsevierViewall">The interventions in both groups are described in the supplementary material. <span class="elsevierStyleItalic">Standard arm:</span> The lung-protective ventilation strategy (STD Group) aims to minimize lung injury by avoiding tidal overdistension and atelectrauma produced by repetitive alveolar opening and closure. This is currently the most widely used approach to intraoperative MV.</p><p id="par0040" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">Study arm:</span> The open lung approach (iOLA Group) aims to homogenize the lung by decreasing the risk of lung injury and subsequent development of PPCs. Most physiological studies have shown benefits of OLA compared to standard management, and some RCTs have shown a reduction in PPCs in other surgical populations.</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Procedures</span><p id="par0045" class="elsevierStylePara elsevierViewall">Patients will be monitored and managed following general high standard-of-care practices. Intraoperative and immediate postoperative anaesthesia management (unrelated to ventilatory management) will be decided by the attending physician following the protocols established in each centre.</p><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Monitoring</span><p id="par0050" class="elsevierStylePara elsevierViewall">Intraoperative monitoring will include electrocardiogram (ECG), pulse oximetry (SpO<span class="elsevierStyleInf">2</span>), capnography, temperature, anaesthesia depth, neuromuscular blockade (with train-of-four) and non-invasive or invasive blood pressure. Ventilatory parameters monitored by the anaesthesia machine include VT, respiratory rate (RR), PEEP, inspiratory oxygen fraction (FiO<span class="elsevierStyleInf">2</span>), peak airway pressure (Paw), plateau pressure (Pplat) and lung dynamic compliance (Cdyn). Postoperative monitoring will include at least ECG, SpO<span class="elsevierStyleInf">2</span>, and arterial pressure.</p></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">General intraoperative ventilatory management</span><p id="par0055" class="elsevierStylePara elsevierViewall">Patients will be ventilated in volume-controlled mode with V<span class="elsevierStyleInf">T</span> 8 ml/kg of predicted body weight (PBW) and PEEP 5 cmH<span class="elsevierStyleInf">2</span>0. The RR will be adjusted to guarantee normocapnia (EtCO<span class="elsevierStyleInf">2</span> between 35 and 45 mmHg). After successful tracheal intubation, FiO<span class="elsevierStyleInf">2</span> will be set to 0.21 for the first 5 min or up to SpO<span class="elsevierStyleInf">2</span> < 97% (air test). Only patients with a positive post-induction air test (SpO<span class="elsevierStyleInf">2</span> < 97% at FiO<span class="elsevierStyleInf">2</span> 0.21) as a clinical sign of atelectasis will be included in the study and randomised. After this, FiO<span class="elsevierStyleInf">2</span> will be set to a minimum of 0.4. During anaesthesia eduction (when the patient starts spontaneous ventilation), FiO<span class="elsevierStyleInf">2</span> will set to 0.8 in all patients. The PEEP level adjusted according to protocol will be maintained until extubation. Once extubated, FiO<span class="elsevierStyleInf">2</span> will be decreased to 0.5 through a Venturi mask within the first 30 min.</p></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Specific intraoperative ventilatory management</span><p id="par0060" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">STD-arm</span>: Patients will be ventilated as previously described.</p><p id="par0065" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">iOLA-arm</span>: RM will be performed and PEEP will be individualised before the start of surgery (<a class="elsevierStyleCrossRef" href="#fig0010">Fig. 2</a>).</p><elsevierMultimedia ident="fig0010"></elsevierMultimedia><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Alveolar recruitment manoeuvre A</span><p id="par0070" class="elsevierStylePara elsevierViewall">To start the RM, the ventilatory mode will be changed to pressure controlled ventilation (PCV) with pressure 20 cmH<span class="elsevierStyleInf">2</span>O, RR 15 rpm, I:E ratio 1:1, FiO<span class="elsevierStyleInf">2</span> 0.8, and PEEP 10 cmH<span class="elsevierStyleInf">2</span>O. PEEP will be increased by 5 cmH<span class="elsevierStyleInf">2</span>O every 3 respiratory cycles, maintaining 5 cycles at the last PEEP level (20 cmH<span class="elsevierStyleInf">2</span>O) to achieve an airway opening pressure of 40 cmH<span class="elsevierStyleInf">2</span>O.</p></span><span id="sec0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">Decremental PEEP trial A</span><p id="par0075" class="elsevierStylePara elsevierViewall">The ventilatory mode will be changed again to volume-controlled ventilation (VCV) with V<span class="elsevierStyleInf">T</span> 8 ml/kg, RR 15 rpm and PEEP 16 cmH<span class="elsevierStyleInf">2</span>O. PEEP will be reduced by 2 cmH<span class="elsevierStyleInf">2</span>O every 15 s until optimal Cdyn is achieved. Once the optimal PEEP level (PEEP with optimal Cdyn) has been determined, a new RM will be performed with optimal PEEP.</p><p id="par0080" class="elsevierStylePara elsevierViewall">The need for new RMs and PEEP trials will be assessed every 60 min by determining SpO<span class="elsevierStyleInf">2</span> during the air test (FiO<span class="elsevierStyleInf">2</span> 0.21 for 5 min or up to SpO<span class="elsevierStyleInf">2</span> < 97%). In patients with a positive air test, a new RM will be performed, but with an airway opening pressure of 45 cmH<span class="elsevierStyleInf">2</span>O and the PEEP trial will start at 20 cmH<span class="elsevierStyleInf">2</span>0 (RM and decremental PEEP trial B, as described in the supplementary material)</p></span></span><span id="sec0060" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0110">General initial (first 30 min) postoperative care</span><p id="par0085" class="elsevierStylePara elsevierViewall">Management, other than postoperative respiratory support, will be at the discretion of the attending physicians following established protocols in each hospital. Initially, all patients will received supplemental oxygen via a Venturi face mask at FiO<span class="elsevierStyleInf">2</span> 0·5. After 15−30 min, once patients are awake, collaborative, and under pain control, lung collapse will be assessed by performing an air test (i.e., reducing FiO<span class="elsevierStyleInf">2</span> from 0.5 to 0.21 for at least 5 min). The air test will not be performed in patients with SpO<span class="elsevierStyleInf">2</span> < 96%. In patients that are still intubated, the foregoing procedure will start after extubation. Postoperative rescue manoeuvres during this period are protocolised for each group (supplementary material).</p></span><span id="sec0065" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0115">Specific postoperative ventilatory management</span><p id="par0090" class="elsevierStylePara elsevierViewall">STD-arm: Patients will be oxygenated via a Venturi mask with a minimum FiO<span class="elsevierStyleInf">2</span> for SpO<span class="elsevierStyleInf">2</span> ≥ 92% for the first 6 post-operative hours.</p><p id="par0095" class="elsevierStylePara elsevierViewall">iOLA-arm: Patients with a negative air test (SpO<span class="elsevierStyleInf">2</span> ≥ 97%) performed 15−30 min after PACU/ICU admission will received the minimum FiO<span class="elsevierStyleInf">2</span> for SpO<span class="elsevierStyleInf">2</span> ≥ 92%. Patients with a positive air test (SpO<span class="elsevierStyleInf">2</span> ≤ 96%) will be treated with high-flow oxygen therapy (HFNT) at 50 L/min<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">19</span></a> and minimum FiO<span class="elsevierStyleInf">2</span> for SpO<span class="elsevierStyleInf">2</span> ≥ 92% for the following 6 post-operative hours.</p></span></span><span id="sec0070" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0120">Duration of follow-up</span><p id="par0100" class="elsevierStylePara elsevierViewall">Each patient will be followed for 30 days from the start of anaesthesia induction.</p><span id="sec0075" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0125">Data collection time points</span><p id="par0105" class="elsevierStylePara elsevierViewall">Intraoperative:<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">-</span><p id="par0110" class="elsevierStylePara elsevierViewall">T1: 10 min after intubation.</p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">-</span><p id="par0115" class="elsevierStylePara elsevierViewall">T2: 60 min after start of MV.</p></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">-</span><p id="par0120" class="elsevierStylePara elsevierViewall">T3: at the end of surgery and prior to extubation.</p></li></ul></p><p id="par0125" class="elsevierStylePara elsevierViewall">Postoperative:<ul class="elsevierStyleList" id="lis0010"><li class="elsevierStyleListItem" id="lsti0020"><span class="elsevierStyleLabel">-</span><p id="par0130" class="elsevierStylePara elsevierViewall">T1: 6 h after admission to PACU/ICU.</p></li><li class="elsevierStyleListItem" id="lsti0025"><span class="elsevierStyleLabel">-</span><p id="par0135" class="elsevierStylePara elsevierViewall">T2: 24 h after surgery.</p></li><li class="elsevierStyleListItem" id="lsti0030"><span class="elsevierStyleLabel">-</span><p id="par0140" class="elsevierStylePara elsevierViewall">T3: 72 h after surgery.</p></li><li class="elsevierStyleListItem" id="lsti0035"><span class="elsevierStyleLabel">-</span><p id="par0145" class="elsevierStylePara elsevierViewall">T4: 5 days after surgery.</p></li><li class="elsevierStyleListItem" id="lsti0040"><span class="elsevierStyleLabel">-</span><p id="par0150" class="elsevierStylePara elsevierViewall">T5: 7 days after surgery.</p></li><li class="elsevierStyleListItem" id="lsti0045"><span class="elsevierStyleLabel">-</span><p id="par0155" class="elsevierStylePara elsevierViewall">T6: 30 days after surgery.</p></li></ul></p></span></span><span id="sec0080" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0130">Outcomes</span><span id="sec0085" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0135">Primary outcome</span><p id="par0160" class="elsevierStylePara elsevierViewall">Efficacy of the individualized perioperative open lung ventilatory strategy, which includes intraoperative RM, individualized PEEP, and individualized postoperative respiratory support to reduce postoperative pulmonary complications for the first 7 postoperative days compared to conventional lung protective ventilation in emergency abdominal surgery patients in whom the presence of intraoperative alveolar collapse has been diagnosed through the air test manoeuvre.</p></span><span id="sec0090" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0140">Secondary outcomes</span><p id="par0165" class="elsevierStylePara elsevierViewall"><ul class="elsevierStyleList" id="lis0015"><li class="elsevierStyleListItem" id="lsti0050"><span class="elsevierStyleLabel">1</span><p id="par0170" class="elsevierStylePara elsevierViewall">Benefit of the perioperative OLA, defined as PaO<span class="elsevierStyleInf">2</span>/FIO<span class="elsevierStyleInf">2</span> > 350 at the end of surgery and 6 h postoperatively, in reducing postoperative pulmonary complications during the first 7 postoperative days compared to no OLA.</p></li><li class="elsevierStyleListItem" id="lsti0055"><span class="elsevierStyleLabel">2</span><p id="par0175" class="elsevierStylePara elsevierViewall">Effectiveness of the individualized perioperative OLA compared with conventional lung protective ventilation to reduce postoperative pulmonary and systemic complications, ICU admissions, ICU and hospital length of stay, and mortality during the first 30 postoperative days and 1 year after surgery.</p></li><li class="elsevierStyleListItem" id="lsti0060"><span class="elsevierStyleLabel">3</span><p id="par0180" class="elsevierStylePara elsevierViewall">Benefit of perioperative open lung (defined as PaO<span class="elsevierStyleInf">2</span>/FiO<span class="elsevierStyleInf">2</span> > 400 mmHg) compared with non-open lung in the reduction of postoperative pulmonary and systemic complications, ICU admissions, ICU and hospital length of stay and mortality during the first 30 postoperative.</p></li></ul></p></span><span id="sec0095" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0145">Main study endpoints</span><p id="par0185" class="elsevierStylePara elsevierViewall">A composite of severe postoperative pulmonary complications appearing within the first 7 postoperative days. Postoperative pulmonary complications will include any of the following: (1) Respiratory failure, (2) Pneumothorax, (3) Weaning failure, (4) Acute respiratory distress syndrome (ARDS), 5) Pulmonary infection.</p></span><span id="sec0100" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0150">Secondary study endpoints</span><p id="par0190" class="elsevierStylePara elsevierViewall"><ul class="elsevierStyleList" id="lis0020"><li class="elsevierStyleListItem" id="lsti0065"><span class="elsevierStyleLabel">-</span><p id="par0195" class="elsevierStylePara elsevierViewall">Postoperative pulmonary complications defined as in the main endpoint, but appearing within 30 days of surgery.</p></li><li class="elsevierStyleListItem" id="lsti0070"><span class="elsevierStyleLabel">-</span><p id="par0200" class="elsevierStylePara elsevierViewall">Postoperative pulmonary complications not included in the primary outcome variable appearing within the first 7 postoperative days and between days 7 and 30 after the intervention. These include: (1) Atelectasis, (2) Pleural effusion, (3) Bronchospasm, (4) Aspiration pneumonitis, (5) Pulmonary thromboembolism, (6) Pulmonary oedema.</p></li><li class="elsevierStyleListItem" id="lsti0075"><span class="elsevierStyleLabel">-</span><p id="par0205" class="elsevierStylePara elsevierViewall">Number of severe and non-severe pulmonary complications per patient.</p></li><li class="elsevierStyleListItem" id="lsti0080"><span class="elsevierStyleLabel">-</span><p id="par0210" class="elsevierStylePara elsevierViewall">Postoperative non-pulmonary complications within the first 7 postoperative days and between days 7 and 30 after the intervention. These include: (1) Cardiac ischaemia, (2) <span class="elsevierStyleItalic">de novo</span> arrhythmia, (3) Heart failure, (4) Sepsis, (5) Septic shock, (6) Acute renal failure, (7) Surgical wound infection, (8) Urinary infection, (9) Delirium, (10) Multiorgan failure, (11) Paralytic ileus, (12) Anastomotic dehiscence, (13) Postoperative haemorrhage.</p></li><li class="elsevierStyleListItem" id="lsti0085"><span class="elsevierStyleLabel">-</span><p id="par0215" class="elsevierStylePara elsevierViewall">Patients that have received intraoperative and postoperative rescue manoeuvres.</p></li><li class="elsevierStyleListItem" id="lsti0090"><span class="elsevierStyleLabel">-</span><p id="par0220" class="elsevierStylePara elsevierViewall">Composite of infectious complications.</p></li><li class="elsevierStyleListItem" id="lsti0095"><span class="elsevierStyleLabel">-</span><p id="par0225" class="elsevierStylePara elsevierViewall">Composite of cardiac complications.</p></li><li class="elsevierStyleListItem" id="lsti0100"><span class="elsevierStyleLabel">-</span><p id="par0230" class="elsevierStylePara elsevierViewall">Patients with any pulmonary and non-pulmonary complications.</p></li><li class="elsevierStyleListItem" id="lsti0105"><span class="elsevierStyleLabel">-</span><p id="par0235" class="elsevierStylePara elsevierViewall">Hospital length of stay between groups and between patients with and without PPCs.</p></li><li class="elsevierStyleListItem" id="lsti0110"><span class="elsevierStyleLabel">-</span><p id="par0240" class="elsevierStylePara elsevierViewall">Mortality within 30 days of the intervention.</p></li><li class="elsevierStyleListItem" id="lsti0115"><span class="elsevierStyleLabel">-</span><p id="par0245" class="elsevierStylePara elsevierViewall">As an exploratory analysis, all outcomes in the STD and iOLA groups will be compared with outcomes in patients not included in the protocol (patients with a negative postinduction air test).</p></li></ul></p><p id="par0250" class="elsevierStylePara elsevierViewall">Postoperative complications and perioperative outcome measurements are defined according to the joint taskforce of the European Society of Anaesthesiology and the European Society of Intensive Care Medicine (supplementary material).<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">20</span></a></p></span><span id="sec0105" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0155">Other variables and definitions</span><p id="par0255" class="elsevierStylePara elsevierViewall"><ul class="elsevierStyleList" id="lis0025"><li class="elsevierStyleListItem" id="lsti0120"><span class="elsevierStyleLabel">-</span><p id="par0260" class="elsevierStylePara elsevierViewall">Age, sex, height, body weight, body mass index, ASA status, Charlson, SOFA, ARISCAT scales, Clinical Frailty scale, preoperative oxygenation (SpO<span class="elsevierStyleInf">2</span>), type of intervention, co-morbidities (pathology, medication, etc).</p></li><li class="elsevierStyleListItem" id="lsti0125"><span class="elsevierStyleLabel">-</span><p id="par0265" class="elsevierStylePara elsevierViewall">Intraoperative parameters: gas exchange, acid-base balance, respiratory and haemodynamic variables, quantitative neuromuscular management, pharmacological reversal neuromuscular blockade, postoperative residual curarization.</p></li><li class="elsevierStyleListItem" id="lsti0130"><span class="elsevierStyleLabel">-</span><p id="par0270" class="elsevierStylePara elsevierViewall">Anaesthetic drugs, anaesthesia techniques (epidural, paravertebral), fluid therapy, and informational parameters such as surgical time, mechanical ventilation time, intraoperative bleeding, urine output, etc.</p></li></ul></p></span></span><span id="sec0110" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0160">Statistical analysis and sample size</span><span id="sec0115" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0165">Sample size</span><p id="par0275" class="elsevierStylePara elsevierViewall">The sample size for the main objective has been calculated for a 95% confidence level, 35% of pulmonary complications at 7 days post-intervention based on the literature,<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a> and a power of 80% to detect an absolute reduction of 10% in the incidence of pulmonary complications. Assuming a loss rate of 5%, the final sample size is 732 patients (366 per group). The sample size calculation will be readjusted during the pre-planned interim analysis.</p></span><span id="sec0120" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0170">Statistical analysis</span><p id="par0280" class="elsevierStylePara elsevierViewall">Patient characteristics will be described as frequencies and percentages in the case of categorical variables, and as mean and standard deviation or median and interquartile range in the case of continuous variables, depending on normality. Categorical variables will be compared using the Chi-square or the Fisher test, and the magnitude of the association will be measured by relative risks or odds ratios. Continuous variables will be compared using the Student t-test or the Mann–Whitney U test, depending on normality. The baseline characteristics of the control group and the intervention group will be compared, and if differences are found in potentially confounding variables they will be included as adjustment variables in the corresponding multivariate models. The main outcome variable will be expressed as a proportion of complications along with a 95% confidence interval. Difference of proportions testing will be performed to compare the intervention and control groups. Time-to-event variables, such as time to the primary or secondary outcome, will be analysed using Kaplan–Meier curves and Cox models of proportional hazards. Variables with different measurements over time will be analysed using mixed linear models. A significance level of α = 0.05 will be considered.</p></span><span id="sec0125" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0175">Missing data</span><span id="sec0130" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0180">Missing primary outcome data</span><p id="par0285" class="elsevierStylePara elsevierViewall">We do not expect data on the primary outcome measure to be missing, and only complete cases will be analysed.</p><p id="par0290" class="elsevierStylePara elsevierViewall">All analyses will be performed by intention to process, and missing data will be processed using multiple imputation methods when more than 5% appear in the secondary outcome variables.</p></span></span><span id="sec0135" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0185">Randomization and minimization of biases</span><span id="sec0140" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0190">Randomization</span><p id="par0295" class="elsevierStylePara elsevierViewall">Patients who meet all of the inclusion criteria and none of the exclusion criteria will be randomized to either the iOLA or STD group. Randomization will be done online on <a href="http://www.iprove-network.es">www.iprove-network.es</a> following the Mersenne Twister algorithm. Investigators at each study site will download the study documents, training videos, and IPs from the Iprove website.</p></span><span id="sec0145" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0195">Blinding</span><p id="par0300" class="elsevierStylePara elsevierViewall">Due to the study design, investigators cannot be blinded during the intraoperative and immediate postoperative period. A second investigator, blinded to the randomization arm, will be responsible for recording the primary and secondary outcomes. The investigators in charge of the statistical analysis and the study sponsor will be blinded to both study groups (except for analyses at the pre-specified times).</p></span></span></span><span id="sec0150" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0200">Severe adverse events (SAE)</span><p id="par0305" class="elsevierStylePara elsevierViewall">A special form has been designed to record adverse events. Based on current knowledge, patients are unlikely to present study-related adverse events other than those usually encountered in mechanically ventilated patients during lung recruitment manoeuvres. Potential RM-related adverse events include haemodynamic instability and, exceptionally, cardiac electrical changes associated with haemodynamic instability, and pneumothorax. These adverse events will be treated immediately following standard clinical management protocols.</p></span><span id="sec0155" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0205">Monitoring plan</span><p id="par0310" class="elsevierStylePara elsevierViewall">The monitoring plan is based on the modified Haybittle-Peto threshold for stopping a trial after an interim analysis performed in the second half of the inclusion period. The analysis of the main outcome variable will be presented to the Data and Safety Management Committee (DSMC), which will be blinded to the study groups. The interim analysis will be performed once the efficacy variables of the first 366 patients have been obtained. If the interim analysis is significant (P < 0.001) both positively and negatively for the intervention group, the DSMC may stop patient recruitment.</p><span id="sec0160" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0210">Monitoring</span><p id="par0315" class="elsevierStylePara elsevierViewall">The trial will be externally monitored according to the GCP Directive and the monitoring and data verification plan. After consent has been obtained, study sites will be monitored centrally for compliance and adherence to the protocol through the online case report form (eCRF).</p></span></span></span><span id="sec0165" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0215">Limitations and strengths of the study</span><span id="sec0170" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0220">Potential limitations</span><p id="par0320" class="elsevierStylePara elsevierViewall">No clinical limitations have been identified for this study. The only potential limitations are impossibility of performing the RM and PEEP trial in a particular patient due to their intraoperative haemodynamic instability, or refusal by a particular patient to receive non-invasive ventilation during the postoperative period. Another potential limitation is that the extent of atelectasis (which cannot be evaluated with the monitoring tools available) may affect our assessment of the effectiveness of both strategies in preventing PPCs.</p></span><span id="sec0175" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0225">Strength and impact</span><p id="par0325" class="elsevierStylePara elsevierViewall">If our hypothesis is correct, this strategy will considerably reduce postoperative complications, ICU and hospital length of stay, and healthcare costs. This is also the first study that prospectively evaluates the benefits of using a perioperative open-lung approach, regardless of the ventilatory management strategy.</p></span></span><span id="sec0180" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0230">Trial registration</span><p id="par0330" class="elsevierStylePara elsevierViewall">Clinicaltrials.gov identifier: NCT04229810. Ethics Committee number: HCB/2020/0030</p></span><span id="sec0185" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0235">Trial funding</span><p id="par0335" class="elsevierStylePara elsevierViewall">None.</p></span><span id="sec0190" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0240">Compensation</span><p id="par0340" class="elsevierStylePara elsevierViewall">Neither the study sites, researchers, or patients will receive compensation.</p></span><span id="sec0195" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0245">Conflict of interest</span><p id="par0350" class="elsevierStylePara elsevierViewall">The authors have no conflict of interest to declare.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:12 [ 0 => array:3 [ "identificador" => "xres2199357" "titulo" => "Abstract" "secciones" => array:3 [ 0 => array:2 [ "identificador" => "abst0005" "titulo" => "Background" ] 1 => array:2 [ "identificador" => "abst0010" "titulo" => "Methods" ] 2 => array:2 [ "identificador" => "abst0015" "titulo" => "Discussion" ] ] ] 1 => array:2 [ "identificador" => "xpalclavsec1845983" "titulo" => "Keywords" ] 2 => array:3 [ "identificador" => "xres2199358" "titulo" => "Resumen" "secciones" => array:3 [ 0 => array:2 [ "identificador" => "abst0020" "titulo" => "Antecedentes" ] 1 => array:2 [ "identificador" => "abst0025" "titulo" => "Métodos" ] 2 => array:2 [ "identificador" => "abst0030" "titulo" => "Discusión" ] ] ] 3 => array:2 [ "identificador" => "xpalclavsec1845982" "titulo" => "Palabras clave" ] 4 => array:2 [ "identificador" => "sec0005" "titulo" => "Background" ] 5 => array:3 [ "identificador" => "sec0010" "titulo" => "Methods" "secciones" => array:9 [ 0 => array:2 [ "identificador" => "sec0015" "titulo" => "Study design" ] 1 => array:2 [ "identificador" => "sec0020" "titulo" => "Participants" ] 2 => array:2 [ "identificador" => "sec0025" "titulo" => "Interventions" ] 3 => array:3 [ "identificador" => "sec0030" "titulo" => "Procedures" "secciones" => array:5 [ 0 => array:2 [ "identificador" => "sec0035" "titulo" => "Monitoring" ] 1 => array:2 [ "identificador" => "sec0040" "titulo" => "General intraoperative ventilatory management" ] 2 => array:3 [ "identificador" => "sec0045" "titulo" => "Specific intraoperative ventilatory management" "secciones" => array:2 [ 0 => array:2 [ "identificador" => "sec0050" "titulo" => "Alveolar recruitment manoeuvre A" ] 1 => array:2 [ "identificador" => "sec0055" "titulo" => "Decremental PEEP trial A" ] ] ] 3 => array:2 [ "identificador" => "sec0060" "titulo" => "General initial (first 30 min) postoperative care" ] 4 => array:2 [ "identificador" => "sec0065" "titulo" => "Specific postoperative ventilatory management" ] ] ] 4 => array:3 [ "identificador" => "sec0070" "titulo" => "Duration of follow-up" "secciones" => array:1 [ 0 => array:2 [ "identificador" => "sec0075" "titulo" => "Data collection time points" ] ] ] 5 => array:3 [ "identificador" => "sec0080" "titulo" => "Outcomes" "secciones" => array:5 [ 0 => array:2 [ "identificador" => "sec0085" "titulo" => "Primary outcome" ] 1 => array:2 [ "identificador" => "sec0090" "titulo" => "Secondary outcomes" ] 2 => array:2 [ "identificador" => "sec0095" "titulo" => "Main study endpoints" ] 3 => array:2 [ "identificador" => "sec0100" "titulo" => "Secondary study endpoints" ] 4 => array:2 [ "identificador" => "sec0105" "titulo" => "Other variables and definitions" ] ] ] 6 => array:3 [ "identificador" => "sec0110" "titulo" => "Statistical analysis and sample size" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "sec0115" "titulo" => "Sample size" ] 1 => array:2 [ "identificador" => "sec0120" "titulo" => "Statistical analysis" ] 2 => array:3 [ "identificador" => "sec0125" "titulo" => "Missing data" "secciones" => array:1 [ 0 => array:2 [ "identificador" => "sec0130" "titulo" => "Missing primary outcome data" ] ] ] 3 => array:3 [ "identificador" => "sec0135" "titulo" => "Randomization and minimization of biases" "secciones" => array:2 [ 0 => array:2 [ "identificador" => "sec0140" "titulo" => "Randomization" ] 1 => array:2 [ "identificador" => "sec0145" "titulo" => "Blinding" ] ] ] ] ] 7 => array:2 [ "identificador" => "sec0150" "titulo" => "Severe adverse events (SAE)" ] 8 => array:3 [ "identificador" => "sec0155" "titulo" => "Monitoring plan" "secciones" => array:1 [ 0 => array:2 [ "identificador" => "sec0160" "titulo" => "Monitoring" ] ] ] ] ] 6 => array:3 [ "identificador" => "sec0165" "titulo" => "Limitations and strengths of the study" "secciones" => array:2 [ 0 => array:2 [ "identificador" => "sec0170" "titulo" => "Potential limitations" ] 1 => array:2 [ "identificador" => "sec0175" "titulo" => "Strength and impact" ] ] ] 7 => array:2 [ "identificador" => "sec0180" "titulo" => "Trial registration" ] 8 => array:2 [ "identificador" => "sec0185" "titulo" => "Trial funding" ] 9 => array:2 [ "identificador" => "sec0190" "titulo" => "Compensation" ] 10 => array:2 [ "identificador" => "sec0195" "titulo" => "Conflict of interest" ] 11 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2023-07-11" "fechaAceptado" => "2023-11-16" "PalabrasClave" => array:2 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec1845983" "palabras" => array:4 [ 0 => "Postoperative pulmonary complications" 1 => "Emergency surgery" 2 => "Open lung ventilatory strategy" 3 => "Recruitment maneuvers" ] ] ] "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec1845982" "palabras" => array:4 [ 0 => "Complicaciones pulmonares postoperatorias" 1 => "Cirugía de urgencia" 2 => "Estrategia ventilatoria a pulmón abierto" 3 => "Maniobras de reclutamiento" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "en" => array:3 [ "titulo" => "Abstract" "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Background</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Postoperative pulmonary complications (PPC) are the most frequent postoperative complications, with an estimated prevalence in elective surgery ranging from 20% in observational cohort studies to 40% in randomized clinical trials. However, the prevalence of PPCs in patients undergoing emergency abdominal surgery is not well defined. Lung-protective ventilation aims to minimize ventilator-induced lung injury and reduce PPCs. The open lung approach (OLA), which combines recruitment manoeuvres (RM) and positive end-expiratory pressure (PEEP) titration, aims to minimize areas of atelectasis and the development of PPCs; however, there is no conclusive evidence in the literature that OLA can prevent PPCs. The purpose of this study is to compare an individualized perioperative OLA with conventional standardized lung-protective ventilation in patients undergoing emergency abdominal surgery with clinical signs of intraoperative lung collapse.</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Methods</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">Randomized international clinical trial to compare an individualized perioperative OLA (RM plus individualized PEEP and individualized postoperative respiratory support) with conventional lung-protective ventilation (standard PEEP of 5 cmH<span class="elsevierStyleInf">2</span>O and conventional postoperative oxygen therapy) in patients undergoing emergency abdominal surgery with clinical signs of lung collapse. Patients will be randomised to open-label parallel groups. The primary outcome is any severe PPC during the first 7 postoperative days, including: acute respiratory failure, pneumothorax, weaning failure, acute respiratory distress syndrome, and pulmonary infection. The estimated sample size is 732 patients (366 per group). The final sample size will be readjusted during the interim analysis.</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Discussion</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">The Individualized Perioperative Open-lung Ventilatory Strategy in emergency abdominal laparotomy (iPROVE-EAL) is the first multicentre, randomized, controlled trial to investigate whether an individualized perioperative approach prevents PPCs in patients undergoing emergency surgery.</p></span>" "secciones" => array:3 [ 0 => array:2 [ "identificador" => "abst0005" "titulo" => "Background" ] 1 => array:2 [ "identificador" => "abst0010" "titulo" => "Methods" ] 2 => array:2 [ "identificador" => "abst0015" "titulo" => "Discussion" ] ] ] "es" => array:3 [ "titulo" => "Resumen" "resumen" => "<span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0030">Antecedentes</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Las complicaciones pulmonares postoperatorias (CPP) son las complicaciones postoperatorias más frecuentes, con una prevalencia estimada en cirugía electiva que oscila entre el 20% en estudios de cohortes observacionales y el 40% en ensayos clínicos aleatorizados. Sin embargo, la prevalencia de CPP en los pacientes sometidos a cirugía abdominal urgente no ha sido bien definida. El objetivo de la estrategia de ventilación pulmonar protectora es minimizar la lesión pulmonar favorecida por la ventilación mecánica y reducir las CPP.</p><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">El objetivo de la estrategia de pulmón abierto (OLA), que combina maniobras de reclutamiento (MR) y evaluación de la presión positiva al final de la espiración (PEEP), es minimizar las zonas de atelectasia y el desarrollo de CPP. Sin embargo, no existe evidencia conclusiva en la literatura sobre que OLA pueda prevenir las CPP.</p><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">El objetivo de este estudio es comparar la estrategia OLA perioperatoria individualizada y la ventilación pulmonar protectora estandarizada convencional en pacientes sometidos a cirugía abdominal urgente con signos clínicos de colapso pulmonar intraoperatorio.</p></span> <span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Métodos</span><p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">Ensayo clínico aleatorizado que compara la estrategia OLA perioperatoria individualizada (RM más PEEP individualizada y soporte respiratorio postoperatorio individualizado) y la ventilación pulmonar protectora convencional (PEEP estándar de 5 cmH<span class="elsevierStyleInf">2</span>O y oxigenoterapia postoperatoria convencional) en pacientes sometidos a cirugía abdominal urgente con signos clínicos de colapso pulmonar. Se aleatorizará a los pacientes en grupos paralelos abiertos. El resultado primario es cualquier CPP grave durante los primeros siete días postoperatorios, incluyendo: insuficiencia respiratoria aguda, neumotórax, fallo de destete, síndrome de distrés respiratorio agudo e infección pulmonar. El tamaño de la muestra estimado es de 732 pacientes (366 por grupo). El tamaño de la muestra final se reajustará durante el análisis intermedio.</p></span> <span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Discusión</span><p id="spar0050" class="elsevierStyleSimplePara elsevierViewall">La estrategia ventilatoria de pulmón abierto perioperatoria individualizada en laparotomía/laparoscopia abdominal urgente (iPROVE-EAL) es el primer ensayo controlado aleatorizado multicéntrico que investiga si la estrategia perioperatoria individualizada previene las CPP en los pacientes sometidos a cirugía urgente.</p></span>" "secciones" => array:3 [ 0 => array:2 [ "identificador" => "abst0020" "titulo" => "Antecedentes" ] 1 => array:2 [ "identificador" => "abst0025" "titulo" => "Métodos" ] 2 => array:2 [ "identificador" => "abst0030" "titulo" => "Discusión" ] ] ] ] "multimedia" => array:2 [ 0 => array:8 [ "identificador" => "fig0005" "etiqueta" => "Figure 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 2065 "Ancho" => 2917 "Tamanyo" => 231126 ] ] "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0005" "detalle" => "Figure " "rol" => "short" ] ] "descripcion" => array:1 [ "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Consort flowchart.</p>" ] ] 1 => array:8 [ "identificador" => "fig0010" "etiqueta" => "Figure 2" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr2.jpeg" "Alto" => 3023 "Ancho" => 2091 "Tamanyo" => 814994 ] ] "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0010" "detalle" => "Figure " "rol" => "short" ] ] "descripcion" => array:1 [ "en" => "<p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Protocolized perioperative ventilatory management.</p>" ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:20 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Incidence of mortality and morbidity related to postoperative lung injury in patients who have undergone abdominal or thoracic surgery: a systematic review and meta-analysis" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:3 [ 0 => "A. 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