Intraoperative Protective Mechanical Ventilation in Patients Requiring Emergency Abdominal Surgery

University Hospital, Clermont-Ferrand707 enrolled

Overview

The aim of this study is to compare the effects of a strategy aimed at increasing alveolar recruitment (high PEEP levels adjusted according to driving pressure and recruitment maneuvers) with that of a strategy aimed at minimizing alveolar distension (low PEEP level without recruitment maneuver) on postoperative respiratory failure and mortality in patients receiving low VT ventilation during emergency abdominal surgery.

Emergency abdominal surgery is associated with a high risk of morbidity and mortality. Postoperative pulmonary complications (PPCs) are the second most common surgical complication and adversely influence surgical morbidity. Postoperative respiratory failure (PRF) is one of the most serious pulmonary complication. Two hypotheses can be forward by the literature. First, a low VT lung protective ventilation in combination with a strategy aimed at minimizing alveolar distension by using low PEEP level (and without recruitment maneuver) could improve postoperative outcome while reducing the risk of hemodynamic alterations or, second, could increase the risk of PRF compared with a strategy aimed at increasing alveolar recruitment using higher PEEP level adjusted according to driving pressure in combination with recruitment maneuvers in adult patients undergoing emergency abdominal surgery. Given the uncertainties, and in order to determine the impact of lung protective ventilation strategies on clinical outcomes of high-risk surgical patients, a randomized trial is needed. Our primary hypothesis is that, during low VT ventilation, a strategy aimed at increasing alveolar recruitment by using high PEEP levels adjusted according to driving pressure in combination with recruitment maneuvers could be more effective at reducing PRF and mortality after emergency abdominal surgery than a strategy aimed at minimizing alveolar distension by using lower PEEP without recruitment maneuver. Given the number of patients for whom the question applies, the prevalence and the burden of PPCs, the study can have significant clinical importance and public health implications.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult (≥18 years) * Patients requiring emergency (defined by the need to proceed to surgery within a few hours after diagnosis) * Laparoscopic or non-laparoscopic abdominal surgery under general anesthesia and with an expected duration of at least two hours Exclusion Criteria: * Patients already receiving mechanical ventilation for more than 12 hours before enrollment * Intracranial hypertension * Chronic respiratory disease requiring oxygen therapy or mechanical ventilation at home * Undrained pneumothorax or subcutaneous emphysema * Patients for which death is deemed imminent and inevitable or patients with an underlying disease process with a life expectancy of less than 3 month * Body mass index (BMI) \>40 kg/m2 * Pregnant or breastfeeding women * Patients already enrolled in the IMPROVE-2 trial * Participation in a confounding trial with mortality or PRF as the main endpoint * Patient's or relative's refusal to participate * Guardianship or trusteeship patient * No affiliation to the Social Security system

Locations (28)

University hospital

Angers, France

Hospital

Annecy, France

University hospital

Besançon, France

University Hospital

Bordeaux, France

Hospital

Chalon-sur-Saône, France

University hospital

Clermont-Ferrand, France

University hospital

Dijon, France

University hospital

Grenoble, France

University hospital

Le Mans, France

University hospital

Lille, France

...and 18 more locations

Outcomes

Primary Outcomes

Postoperative respiratory failure

Composite criteria : 1. \- Failure to wean from the ventilator after surgery (Yes or No) 2. \- Requiring unplanned reintubation (Yes or No) 3. \- Curative non-invasive ventilation once extubated postoperatively (Yes or No) 4. \- Death (all cause of mortality) (Yes or No) If at least one of these 4 criteria is answered yes, the composite criterion (i.e. the primary outcome) will be answered yes

Time frame: Hospital discharge - Up to day 30

Secondary Outcomes

Postoperative pulmonary complications

Hypoxemia, pneumonia? development of acute respiratory distress syndrome (ARDS)

Time frame: Day 30

Postoperative extra-pulmonary complications

sepsis and septic shock, renal dysfunction

Time frame: Day 30

SOFA