Intraoperative Protective Mechanical Ventilation in Patients Requiring Emergency Abdominal Surgery (IMPROVE-2)

University Hospital, Clermont-Ferrand

Status: Completed

Conditions: Postoperative Morbidity; General Anesthesia; Mechanical Ventilation; Emergency Abdominal Surgery

Treatments: Other: Driving-pressure-guided group; Other: Low PEEP

Study type: Interventional

Funder types: Other

Identifiers

NCT03987789

IMPROVE-2 study

2019-A00265-52 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 707 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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707 participants in 2 patient groups

Low PEEP group

Active Comparator group

Description:

Patients will receive a PEEP level ≤5 cmH2O without recruitment maneuvers

Treatment:

Other: Low PEEP

Driving-pressure-guided group

Experimental group

Description:

Patients will receive PEEP levels individually set at the highest possible value (up to 15 cmH2O) providing a driving pressure (airway plateau pressure minus PEEP) lower than 13 cmH2O, in addition to recruitment maneuvers

Treatment:

Other: Driving-pressure-guided group