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Emergency Abdominal SurgeryIMPROVE-2NCT03987789

Intraoperative Protective Mechanical Ventilation in Patients Requiring Emergency Abdominal Surgery

A study testing Driving-pressure-guided group and Low PEEP in people with Emergency Abdominal Surgery and Mechanical Ventilation, run by University Hospital, Clermont-Ferrand at 28 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Driving-pressure-guided group and Low PEEP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
707 participants
Where
28 sitesFrance
Study dates
18 Feb 2021to 27 Oct 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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 locations and contacts

28 sites in 1 country.

28 sites in 1 country

France28 sites

  • University hospital

    Angers

  • Hospital

    Annecy

  • University hospital

    Besançon

  • University Hospital

    Bordeaux

  • Hospital

    Chalon-sur-Saône

  • University hospital

    Clermont-Ferrand

  • University hospital

    Dijon

  • University hospital

    Grenoble

  • University hospital

    Le Mans

  • University hospital

    Lille

  • University hospital

    Lyon

  • University hospital

    Marseile

  • Assistance Publique-Hôpitaux de Marseille

    Marseille

  • Institut Paoli Calmette

    Marseille

  • University hospital

    Marseille

  • University hospital

    Montpellier

  • University Hospital

    Nantes

  • University hospital

    Nice

  • University hospital

    Nîmes

  • Assistance Publique-Hôpitaux de Paris

    Paris

  • Hospital

    Périgueux

  • University hospital

    Pointe à Pitre, 97159

  • University hospital

    Rennes

  • University hospital

    Saint-Etienne

  • University hospital

    Strasbourg

  • Hospital

    Suresnes

  • University hospital

    Toulouse

  • Hospital

    Valenciennes

Other trials in France

About this study

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

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.

Read the detailed 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.

Being tested
Driving-pressure-guided group, Low PEEP
Keywords
Mechanical Ventilation, Lung-Protective Ventilation, Postoperative Pulmonary Complications, Postoperative morbidity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Driving-pressure-guided groupOther

    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.

  • Low PEEPOther

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

Study groups in NCT03987789
Study groupRoleWhat they receive
Low PEEP groupActive comparatorPatients will receive a PEEP level ≤5 cmH2O without recruitment maneuvers
Receives: Other: Low PEEP
Driving-pressure-guided groupExperimentalPatients 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
Receives: Other: Driving-pressure-guided group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Hospital discharge - Up to day 30

Secondary outcomes (25)

  1. Postoperative pulmonary complications

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

    Measured: Day 30

  2. Postoperative extra-pulmonary complications

    sepsis and septic shock, renal dysfunction

    Measured: Day 30

  3. SOFA

    Sequential-related Organ Failure Assessment

    Measured: Day 1

  4. SOFA

    Sequential-related Organ Failure Assessment

    Measured: Day 2

  5. SOFA

    Sequential-related Organ Failure Assessment

    Measured: Day 3

  6. SOFA

    Sequential-related Organ Failure Assessment

    Measured: Day 4

  7. SOFA

    Sequential-related Organ Failure Assessment

    Measured: Day 5

  8. SOFA

    Sequential-related Organ Failure Assessment

    Measured: Day 6

  9. SOFA

    Sequential-related Organ Failure Assessment

    Measured: Day 7

  10. Ventilator-free days

    The number of days alive and with unassisted breathing

    Measured: Day 30

  11. Duration of invasive mechanical ventilation

    Duration of invasive mechanical ventilation from randomization to first tracheal extubation

    Measured: Up to Day 30

  12. Total duration of mechanical ventilation

    Total duration of mechanical ventilation (additive, for all épisodes)

    Measured: Up to Day 30

  13. Time to successful tracheal extubation

    Absence of ventilatory support during the first 48 hours after extubation

    Measured: 48 hours

  14. Total volume of intraoperative fluids

    Total volume of intraoperative fluids (crystalloids and colloids)

    Measured: Day 1

  15. Median norepinephrine doses during surgery

    µg/kg/min

    Measured: Day 1

  16. Median phenylephrine doses during surgery

    µg/kg/min

    Measured: Day 1

  17. Median ephedrine doses during surgery

    µg/kg/min

    Measured: Day 1

  18. Intensive care unit (ICU)-free days

    Intensive care unit (ICU)-free days

    Measured: Day 30

  19. Duration of ICU stay

    Duration of ICU stay

    Measured: Up to day 90

  20. Duration of hospital stay

    Duration of hospital stay

    Measured: Up to day 90

  21. All-cause mortality

    All-cause mortality

    Measured: Day 30

  22. All-cause mortality

    All-cause mortality

    Measured: Day 90

  23. Time to death

    Time to death (Days)

    Measured: Up to 90 days

  24. Hemodynamic instability

    Hemodynamic instability ventilatory-related defined as a drop of arterial systolic pressure below 80 mmHg for more than 5 minutes not responding to treatment

    Measured: Up to day 30

  25. Pneumothorax

    Pneumothorax ventilatory-related

    Measured: Up to day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2019
  2. Study start18 Feb 2021
  3. Primary completion29 Jul 2022
  4. Study completion27 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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)
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
707 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03987789
Sponsor's protocol ID
IMPROVE-2 study
Other IDs
2019-A00265-52
Acronym
IMPROVE-2
Status last verified
Apr 2026
First submitted
12 Jun 2019
Last updated
21 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The French National Data Safety Authority (CNIL) forbids making data freely available without prior agreement. Thus, the data underlying study findings cannot be made freely available because of ethical and legal restrictions. However, individual participant data underlying the results reported in the manuscript (text, tables, figures, and appendices) can be obtained after deidentification. Data can be obtained upon request from the IMPROVE-2 steering committee. Readers may contact: efutier@chu-clermontferrand.fr to request the data. The data cannot be freely available for the reasons mentioned above. Data access can be only possible after scientific assessment and data sharing agreement, detailing the type of data requested. This data sharing agreement has to be signed between applicants and the sponsor, Clermont-Ferrand University Hospital.

Publications

  • 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.

    PubMed 40839096

  • 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.

    PubMed 35523498

Questions about this trial

What is this clinical trial studying?

A study testing Driving-pressure-guided group and Low PEEP in people with Emergency Abdominal Surgery and Mechanical Ventilation, run by University Hospital, Clermont-Ferrand at 28 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative respiratory failure (time frame: Hospital discharge - Up to day 30). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03987789, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.

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