Completed

IMPROVE-2Intraoperative Protective Mechanical Ventilation in Patients Requiring Emergency Abdominal Surgery: IMPROVE-2 Multicenter Prospective Randomized Trial

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Driving-pressure-guided group

+ Low PEEP

Other
Who is being recruted

Over 18 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: February 2021
See protocol details

Summary

Principal SponsorUniversity Hospital, Clermont-Ferrand
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 18, 2021

Actual date on which the first participant was enrolled.

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.

Official TitleIntraoperative Protective Mechanical Ventilation in Patients Requiring Emergency Abdominal Surgery: IMPROVE-2 Multicenter Prospective Randomized Trial
NCT03987789
Principal SponsorUniversity Hospital, Clermont-Ferrand
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

707 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

3 inclusion criteria required to participate
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

12 exclusion criteria prevent from participating
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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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

Group II

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

Study Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 28 locations

Suspended

University hospital

Angers, FranceOpen University hospital in Google Maps
Suspended

Hospital

Annecy, France
Suspended

University hospital

Besançon, France
Suspended

University Hospital

Bordeaux, France
Completed28 Study Centers