Intraoperative Protective Mechanical Ventilation in Patients Requiring Emergency Abdominal Surgery

NCT03987789 | Completed DMC

• 2 other identifiers: IMPROVE-2 study2019-A00265-52
• Study Type: interventional
• Target: 707
• Locations: 1 country
• Sites: 28

Brief Summary

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.

Conditions

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

Keywords

Mechanical Ventilation; Lung-Protective Ventilation; Postoperative Pulmonary Complications; Postoperative morbidity

Outcome Measures

Primary Outcomes (1)

• 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

  Hospital discharge - Up to day 30

Secondary Outcomes (25)

• Postoperative pulmonary complications

  Day 30

• Postoperative extra-pulmonary complications

  Day 30

• SOFA

  Day 1

• SOFA

  Day 2

• SOFA

  Day 3

Study Arms (2)

Low PEEP group

ACTIVE COMPARATOR

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

Other: Low PEEP

Driving-pressure-guided group

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

Other: Driving-pressure-guided group

Interventions

Driving-pressure-guided group OTHER

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.

Driving-pressure-guided group

Low PEEP OTHER

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

Low PEEP group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (28)

University hospital

Angers, France

Location

Hospital

Annecy, France

Location

University hospital

Besançon, France

Location

University Hospital

Bordeaux, France

Location

Hospital

Chalon-sur-Saône, France

Location

University hospital

Clermont-Ferrand, France

Location

University hospital

Dijon, France

Location

University hospital

Grenoble, France

Location

University hospital

Le Mans, France

Location

University hospital

Lille, France

Location

University hospital

Lyon, France

Location

University hospital

Marseile, France

Location

Assistance Publique-Hôpitaux de Marseille

Marseille, France

Location

Institut Paoli Calmette

Marseille, France

Location

University hospital

Marseille, France

Location

University hospital

Montpellier, France

Location

University Hospital

Nantes, France

Location

University hospital

Nice, France

Location

University hospital

Nîmes, France

Location

Assistance Publique-Hôpitaux de Paris

Paris, France

Location

Hospital

Périgueux, France

Location

University hospital

Pointe à Pitre, 97159, France

Location

University hospital

Rennes, France

Location

University hospital

Saint-Etienne, France

Location

University hospital

Strasbourg, France

Location

Hospital

Suresnes, France

Location

University hospital

Toulouse, France

Location

Hospital

Valenciennes, France

Location

Related Publications (2)

• Futier E, De Jong A, Cirenei C, Godet T, Jabaudon M, Constantin JM, Grillot N, Bouzat P, Henry L, Margetis D, Lebuffe G, Garnier M, Lambert C, Pereira B, Jaber S; IMPROVE-2 Trial investigators. Personalized driving pressure-guided positive end-expiratory pressure in patients at risk of postoperative respiratory failure (IMPROVE-2): a multicenter, pragmatic, randomized clinical trial. Intensive Care Med. 2025 Oct;51(10):1797-1808. doi: 10.1007/s00134-025-08082-x. Epub 2025 Aug 21.

  PMID: 40839096 RESULT

• Khaled L, Godet T, Jaber S, Chanques G, Asehnoune K, Bourdier J, Araujo L, Futier E, Pereira B. Intraoperative protective mechanical ventilation in patients requiring emergency abdominal surgery: the multicentre prospective randomised IMPROVE-2 study protocol. BMJ Open. 2022 May 6;12(5):e054823. doi: 10.1136/bmjopen-2021-054823.

  PMID: 35523498 DERIVED

Study Officials

• Emmanuel Futier

  CHU de Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: It will not be possible to mask the assigned ventilation strategy from the treating clinicians because they have an ethical responsibility to ensure patient safety during the emergency procedures. However, procedures will be put in place to minimize the possibility of bias arising because research staff becomes aware of trial group allocation. At each participating center, patients will be followed up for primary and secondary endpoints by members of the research staff who will be unaware of the trial group allocation. Information on whether the primary and secondary outcomes occur will be collected and entered into the electronic web-based case report form (eCRF) by trial or clinical trained personal (clinical research associate), blinded to the allocation group, under the supervision of the local principal investigator (PI) or designee who will also be unaware of the trial group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, prospective, randomized, stratified, parallel-group clinical trial with blinded outcome assessment and concealed allocation of patients undergoing emergency abdominal surgery using low VT lung-protective ventilation to a strategy of minimal alveolar distension using low PEEP level or to a strategy aimed at increasing alveolar recruitment (higher PEEP level individually titrated to minimize the driving pressure in addition to recruitment maneuvers)

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: June 17, 2019
• Study Start: February 18, 2021
• Primary Completion: July 29, 2022
• Study Completion: October 27, 2022
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 6 months following article publication. No end date
• Access Criteria: . Data can be obtained upon request from the IMPROVE-2 steering committee. Readers may contact: efutier@chu-clermontferrand.fr to request the data.

Locations

FR (28)