Rationale and study design for an Individualized PeriopeRative Open lung VEntilatory approach in Emergency Abdominal Laparotomy/scopy: study protocol for a prospective international randomized controlled trial.

Autors de IIS La Fe

• Fernando Suárez Sipmann

  Autor

• 

  Óscar Díaz Cambronero

  Autor

• Conrad Pujol Marco

  Autor

• Julian Librero Lopez

  Autor

• Julia Villar Lopez

  Autor

Autors aliens a IIS La Fe

• Laguna G
• Tusman G
• Ripollés J
• Rivas E
• Garutti I
• Mellado R
• Vallverdú J
• Jacas A
• Fervienza A
• Marrero R
• Ferrando C

Grups d'Investigació

• Dermatología y Regeneración Tisular

  

  Leader

  Rafael Botella Estrada

• Medicina Perioperatoria, Anestesiología y Reanimación

  

  Leader

  Óscar Díaz Cambronero

Abstract

BACKGROUND: 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. METHODS: 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(2)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. DISCUSSION: 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.

Copyright © 2024 Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor. Publicado por Elsevier España, S.L.U. All rights reserved.

Keywords

• Cirugía de urgencia; Complicaciones pulmonares postoperatorias; Emergency surgery; Estrategia ventilatoria a pulmón abierto; Maniobras de reclutamiento; Open lung ventilatory strategy; Postoperative pulmonary complications; Recruitment maneuvers