Postoperative Respiratory FailureIMPROVEIIINCT07620132
Mechanical Power for Ventilatory Settings in Operating Room
A study testing Mechanical power-guided ventilatory strategy and Standard fixed ventilatory settings in people with Postoperative Respiratory Failure and Abdominal Surgery, run by University Hospital, Montpellier.
Trial summary
Postoperative respiratory failure (PRF) is a dreaded complication that imposes a significant burden through unplanned admission to the ICU, post discharge disability and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Respiratory Failure, Abdominal Surgery, Postoperative Pulmonary Complications
- What is being tested?
- Mechanical power-guided ventilatory strategy and Standard fixed ventilatory settings
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 490 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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)
- Laparoscopic or non-laparoscopic abdominal surgery
- With an expected duration of at least 2 hours
Who cannot join
- Patients already receiving mechanical ventilation > 12 hours before surgery;
- Chronic respiratory disease requiring oxygen therapy or mechanical ventilation at home;
- Undrained pneumothorax or subcutaneous emphysema;
- Intracranial hypertension;
- Patients for which death is deemed imminent and inevitable or patients with an underlying disease process with a life expectancy of less than 3 months;
- Patients already enrolled in the IMPROVE III trial;
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- Pregnancy in progress or planned during the study period or breastfeeding women (Art. L1121-5 of the French Public Health Code);
- Patients protected by law (Art. L1121-6 to L1121-8 of the French Public Health Code): Individuals deprived of their liberty by judicial or administrative decision, vulnerable persons, minors, adults under guardianship or curatorship;
- Patients not covered by a French social security scheme and not benefiting from such a scheme;
- Absence of free and informed oral consent from the patient before inclusion (except in emergency situation where the patient is unable to provide consent), or absence of written informed consent from his/her proxy if present in an emergency situation (except in life-threatening emergency, where inclusion without consent from the patient or his/her proxy is permitted), in which case consent will be obtained as soon as possible after inclusion.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Mechanical Power for Ventilatory Settings in Operating Room: a Multicenter Randomized Controlled Trial
Postoperative respiratory failure (PRF) is a dreaded complication that imposes a significant burden through unplanned admission to the ICU, post discharge disability and mortality. Despite widespread implementation of intraoperative lung-protective ventilation strategies over the past decade, results remain inconsistent. Interventions targeting individual parameters like tidal volume or positive end-expiratory pressure (PEEP) have shown equivocal results. The use of high PEEP and recruitment maneuvers raises safety concerns by possible negative hemodynamic effects. Recent studies suggest that individualizing ventilation strategies based on mechanical power-a composite parameter integrating tidal volume, plateau pressure, PEEP, and ventilator frequency-may better predict and help prevent PRF, independently of patients' baseline respiratory system compliance. These studies identified this parameter as interventional targets to reduce lung injury during mechanical ventilation. However, no multicenter randomized controlled trial has been performed in the field of ventilatory settings titration during invasive mechanical ventilation in operating room.
The investigators hypothesize that a ventilation strategy aimed at decreasing mechanical power will reduce the incidence of PRF and mortality in patients undergoing abdominal surgery, compared with a standard strategy using fixed tidal volume and PEEP
Read the detailed description
Postoperative respiratory failure (PRF) is a dreaded complication that imposes a significant burden through unplanned admission to the intensive care unit (ICU) and post discharge disability. Respiratory failure evident by tracheal intubations 1 month following nonemergent, noncardiac surgeries has been associated with a nine-fold increase in mortality. Efforts to reduce the rates of PRF have incorporated intraoperative ventilation strategies as a central element, with lung-protective ventilation following recommendations for the ICU setting being broadly implemented over the past decade. Interventions targeting individual parameters like tidal volume have shown equivocal results. To summarize, two randomized clinical trials showed lung-protective ventilation with low tidal volume (VT) in addition to high positive end-expiratory pressure (PEEP) and recruitment maneuver (RM) to prevent against postoperative pulmonary complications when compared with ventilation with high VT plus low PEEP without RM. Two other large, randomized trials found no benefit of high PEEP with RM compared with low PEEP without RM in this setting, suggesting that beneficial effects arise primarily from the use of low VT ventilation. Concerns have also been raised about possible negative hemodynamic effects of high PEEP and RMs in these studies. One size does not fit all. Individualized strategies are needed, such as ones using driving pressure (plateau pressure - PEEP), to perform PEEP titration. Using this calculated parameter, reduced incidence of postoperative pulmonary complications has been demonstrated in small randomized controlled trials, and not achieved in others. However, tidal volume and respiratory rate are also important parameters to limit ventilator induced injuries, and are not considered when assessing driving pressure. Mechanical power, a concept that in addition to tidal volume, plateau pressure and positive end-expiratory pressure (PEEP) also integrates the ventilatory frequency, has been recently associated with a higher risk of PRF. This formula is now implemented in the most recent operating room ventilators, and used in routine by some teams, with lack of evidence showing an efficacy of this strategy to set ventilatory settings. Although it has become clear that high mechanical power identifies patients at risk of PRF both in the operating room and ICU, there is an ongoing debate about whether they are linked to PRF, or whether these parameters merely represent an epiphenomenon in patients with impaired respiratory system mechanics and elevated risk at baseline.
Recently, several studies showed that high mechanical power was associated with PRF independent from patients' baseline respiratory system compliance. These studies identified this parameter as interventional targets to reduce lung injury during mechanical ventilation. However, no multicenter randomized controlled trial has been performed in the field of ventilatory settings titration during invasive mechanical ventilation in operating room.
The investigators made the hypothesis that a strategy aimed at decreasing mechanical power (tidal volume, respiratory rate and PEEP individually titrated to minimize the mechanical power) will reduce PRF and mortality in patients undergoing abdominal surgery, when compared with that of a strategy of standard care (with fixed level of tidal volume and PEEP). The investigators expect decreased PRF and mortality rate in the group "mechanical power-guided ventilatory settings". The investigators also expect in this group reduced duration of postoperative mechanical ventilation, reduced incidence of postoperative organ dysfunction, and reduced duration of hospital stay.
- Conditions
- Postoperative Respiratory Failure, Abdominal Surgery, Postoperative Pulmonary Complications, Morality
- Being tested
- Mechanical power-guided ventilatory strategy, Standard fixed ventilatory settings
- Keywords
- Mechanical ventilation, Intubation, Mechanical power-guided ventilation, Laparoscopic or non-laparoscopic abdominal surgery, Intensive care unit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical power-guided ventilatory strategyProcedure or surgery
- Tidal volume 7ml/kg PBW and RR titrated for EtCO2 between 40-50mmHg. See calculated Mechanical power:0,049*tidal volume*RR*driving pressure.
- Set PEEP 15cmH2O and perform recruitment maneuver at 30cmH2O for 20s. Decrease PEEP from 15 by steps of 2cmH2O until the lower level of PEEP minimizing mechanical power. Note mechanical power. Stop maneuver and/or decrease level of PEEP if decrease>20% of cardiac output during the maneuver, when compared to baseline.
- Repeat this step using 9 ml/kg PBW and choose the optimal tidal volume with lowest mechanical power.
During the surgery, adjust RR to maintain EtCO2 between 40-50mmHg, with an inspiratory-to-expiratory time ratio of 1:2 to 1:1, an end-inspiratory pause of 30%, an FiO2 adjusted to maintain SpO2≥94%. Recruitment maneuvers will be performed after intubation, in case of ventilator disconnection, coelioscopy insufflation, change of position, at the end of surgery, or if mechanical power >30%.
Standard fixed ventilatory settingsProcedure or surgery
Tidal volume 7 ml/kg predicted body weight, calculated according to a predefined formula: 50+0.91 x (centimeters of height - 152.4) for males and 45.5+0.91 x (centimeters of height - 152.4) for females, fixed PEEP between 6 and 8 cmH20, recruitment maneuvers at the discretion of the physician.
The respiratory rate will be adjusted to maintain end-tidal partial pressure of CO2 between 30 and 40 mmHg, a target reported to be used by approximately 90% of physicians according to a recent online survey administered to French anesthesiologists via the French Society of Anesthesia \& Intensive Care Medecine (SFAR), which will be published soon, with an inspiratory-to-expiratory time ratio of 1:2 to 1:1, an end-inspiratory pause of 30 %, and an FiO2 adjusted to maintain SpO2 ≥ 94%.
Mechanical power will not be measured during the surgery to avoid any modification of the ventilatory setting by the physician in charge.
| Study group | Role | What they receive |
|---|---|---|
| Mechanical power-guided ventilatory strategy | Experimental | In the intervention group, ventilatory settings will be personalized according to the mechanical power, after the surgical incision (whether laparoscopy or laparotomy), and after the pneumoperitoneum insufflation (for laparoscopy only) or stop of pneumoperitoneum insufflation. Receives: Procedure: Mechanical power-guided ventilatory strategy |
| Control group with standard fixed ventilatory settings | Active comparator | In the control group, standard care will be performed. Receives: Procedure: Standard fixed ventilatory settings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of postoperative respiratory failure
Defined as failure to wean from the ventilator within the first 12 hours after surgery
Measured: Up to 12 hours after surgery
Composite of postoperative respiratory failure
Defined as the need for unplanned reintubation following the end of surgery, once extubated
Measured: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
Composite of postoperative respiratory failure
Defined as the need for therapeutic non-invasive ventilation following the end of surgery, once extubated
Measured: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
All-cause mortality
Defined as death from any cause occurring within 30 days following surgery. The time to death will be measured from the date of surgery to the date of death. Patients discharged from hospital alive before Day 30 or still alive at Day 30 will be considered censored at that time.
Measured: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
Secondary outcomes (12)
Severity of postoperative pulmonary complications following surgery
The severity of pulmonary complications after surgery will be scored on a grade scale ranging from 0 to 4, with grade 0 representing the absence of any pulmonary complication and grades 1 through 4 representing successively the worse forms of pulmonary complications
Measured: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
Renal dysfunction following surgery
Postoperative renal dysfunction will be assessed using the Kidney Disease: Improving Global Outcomes (KDIGO) Acute Kidney Injury Classification, based on serum creatinine levels and urine output criteria. The KDIGO classification ranges from Stage 0 to Stage 3, where higher stages indicate more severe renal dysfunction (Stage 0 = no acute kidney injury; Stage 3 = most severe acute kidney injury). Renal dysfunction will be defined as KDIGO Stage 1 or higher.
Measured: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
Sepsis and septic shock following surgery
Will be evaluated after surgery, according to the last recommendations on sepsis and septic shock
Measured: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
Sepsis-related Organ Failure Assessment (SOFA)
The SOFA score will be collected at randomization, at Day 1, at Day 7 to evaluate the extent of organ dysfunction. The score includes six organ systems: respiratory, cardiovascular, hepatic, coagulation, renal, and neurological function. Each system is graded from 0 (normal function) to 4 (severe dysfunction) based on objective clinical or laboratory parameters. The Glasgow Coma Score will be excluded from the calculation
Measured: At randomization (day 0), at Day 1, at Day 7
Ventilator-free days (VFDs)
A ventilator-free day is defined as the receipt as < 2 hours of invasive mechanical ventilation or non-invasive mechanical ventilation (as curative therapy) within a 24-hour period
Measured: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
Duration of invasive mechanical ventilation
Measured from the time of initiation of mechanical ventilation to the first tracheal extubation
Measured: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
Total duration of mechanical ventilation
Total duration of invasive mechanical ventilation will be measured in days from the initiation of mechanical ventilation until final discontinuation during the follow-up period. All periods of invasive mechanical ventilation, including episodes requiring reintubation, will be included in the total duration calculation.
Measured: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
Time to successful tracheal extubation
Successful extubation reflects both effective weaning from mechanical ventilation and the patient's ability to maintain adequate spontaneous breathing. it's defined as the interval from the time of initiation of mechanical ventilation to the tracheal extubation that is not followed by reintubation within 7 days
Measured: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
ICU-free days
Are defined as the number of days a patient is both alive and discharged from the intensive care unit (ICU) during the first 30 days following surgery. Patients who die before ICU discharge will be assigned zero ICU-free days. The outcome will be censored at 30 days postoperatively or at the time of hospital discharge, whichever occurs first
Measured: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
Length of ICU stay
Will be measured from the date of ICU admission to the date of discharge from the ICU. Patients who are still in ICU on day 30 will be considered censored at that time
Measured: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
Length of hospital stay
Will be measured from the date of hospital admission to the date of discharge from the hospital. Patients who are transferred to another type of healthcare facility (e.g., rehabilitation center) before Day 30 will be considered as having been discharged from the hospital. Patients who are still in hospital on day 30 will be considered censored at that time
Measured: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
Time to death (or censoring)
Is defined as the time from the date of surgery to the occurrence of death. Data will be collected up to Day 30, or until the date of hospital discharge, if this occurs before Day 30. Patients who do not die during this period will be considered censored at that time
Measured: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- A multicenter randomized controlled trial, comparing two parallel groups, one with mechanical power-guided ventilatory settings (intervention group), the other with standard fixed ventilatory settings
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 490 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Audrey DEBRUS, Dr, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07620132
- Sponsor's protocol ID
- RECHMPL24_0492
- Acronym
- IMPROVEIII
- Status last verified
- May 2026
- First submitted
- 15 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Power for Ventilatory Settings in Operating Room: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07620132
- Acronym / sponsor ID
- IMPROVEIII / RECHMPL24_0492
- Conditions
- Postoperative Respiratory Failure, Abdominal Surgery, Postoperative Pulmonary Complications, Morality
- Keywords
- Mechanical ventilation, Intubation, Mechanical power-guided ventilation, Laparoscopic or non-laparoscopic abdominal surgery, Intensive care unit
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 490 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative respiratory failure (PRF) is a dreaded complication that imposes a significant burden through unplanned admission to the ICU, post discharge disability and mortality. Despite widespread implementation of intraoperative lung-protective ventilation strategies over the past decade, results remain inconsistent. Interventions targeting individual parameters like tidal volume or positive end-expiratory pressure (PEEP) have shown equivocal results. The use of high PEEP and recruitment maneuvers raises safety concerns by possible negative hemodynamic effects. Recent studies suggest that individualizing ventilation strategies based on mechanical power-a composite parameter integrating tidal volume, plateau pressure, PEEP, and ventilator frequency-may better predict and help prevent PRF, independently of patients' baseline respiratory system compliance. These studies identified this parameter as interventional targets to reduce lung injury during mechanical ventilation. However, no multicenter randomized controlled trial has been performed in the field of ventilatory settings titration during invasive mechanical ventilation in operating room.
The investigators hypothesize that a ventilation strategy aimed at decreasing mechanical power will reduce the incidence of PRF and mortality in patients undergoing abdominal surgery, compared with a standard strategy using fixed tidal volume and PEEP
Detailed description
Postoperative respiratory failure (PRF) is a dreaded complication that imposes a significant burden through unplanned admission to the intensive care unit (ICU) and post discharge disability. Respiratory failure evident by tracheal intubations 1 month following nonemergent, noncardiac surgeries has been associated with a nine-fold increase in mortality. Efforts to reduce the rates of PRF have incorporated intraoperative ventilation strategies as a central element, with lung-protective ventilation following recommendations for the ICU setting being broadly implemented over the past decade. Interventions targeting individual parameters like tidal volume have shown equivocal results. To summarize, two randomized clinical trials showed lung-protective ventilation with low tidal volume (VT) in addition to high positive end-expiratory pressure (PEEP) and recruitment maneuver (RM) to prevent against postoperative pulmonary complications when compared with ventilation with high VT plus low PEEP without RM. Two other large, randomized trials found no benefit of high PEEP with RM compared with low PEEP without RM in this setting, suggesting that beneficial effects arise primarily from the use of low VT ventilation. Concerns have also been raised about possible negative hemodynamic effects of high PEEP and RMs in these studies. One size does not fit all. Individualized strategies are needed, such as ones using driving pressure (plateau pressure - PEEP), to perform PEEP titration. Using this calculated parameter, reduced incidence of postoperative pulmonary complications has been demonstrated in small randomized controlled trials, and not achieved in others. However, tidal volume and respiratory rate are also important parameters to limit ventilator induced injuries, and are not considered when assessing driving pressure. Mechanical power, a concept that in addition to tidal volume, plateau pressure and positive end-expiratory pressure (PEEP) also integrates the ventilatory frequency, has been recently associated with a higher risk of PRF. This formula is now implemented in the most recent operating room ventilators, and used in routine by some teams, with lack of evidence showing an efficacy of this strategy to set ventilatory settings. Although it has become clear that high mechanical power identifies patients at risk of PRF both in the operating room and ICU, there is an ongoing debate about whether they are linked to PRF, or whether these parameters merely represent an epiphenomenon in patients with impaired respiratory system mechanics and elevated risk at baseline.
Recently, several studies showed that high mechanical power was associated with PRF independent from patients' baseline respiratory system compliance. These studies identified this parameter as interventional targets to reduce lung injury during mechanical ventilation. However, no multicenter randomized controlled trial has been performed in the field of ventilatory settings titration during invasive mechanical ventilation in operating room.
The investigators made the hypothesis that a strategy aimed at decreasing mechanical power (tidal volume, respiratory rate and PEEP individually titrated to minimize the mechanical power) will reduce PRF and mortality in patients undergoing abdominal surgery, when compared with that of a strategy of standard care (with fixed level of tidal volume and PEEP). The investigators expect decreased PRF and mortality rate in the group "mechanical power-guided ventilatory settings". The investigators also expect in this group reduced duration of postoperative mechanical ventilation, reduced incidence of postoperative organ dysfunction, and reduced duration of hospital stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A multicenter randomized controlled trial, comparing two parallel groups, one with mechanical power-guided ventilatory settings (intervention group), the other with standard fixed ventilatory settings
| Arm | Type | Receives |
|---|---|---|
| Mechanical power-guided ventilatory strategy | Experimental | Procedure: Mechanical power-guided ventilatory strategyIn the intervention group, ventilatory settings will be personalized according to the mechanical power, after the surgical incision (whether laparoscopy or laparotomy), and after the pneumoperitoneum insufflation (for laparoscopy only) or stop of pneumoperitoneum insufflation. |
| Control group with standard fixed ventilatory settings | Active comparator | Procedure: Standard fixed ventilatory settingsIn the control group, standard care will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult (≥ 18 years)
- Laparoscopic or non-laparoscopic abdominal surgery
- With an expected duration of at least 2 hours
Key exclusion criteria (10 listed)
- Patients already receiving mechanical ventilation > 12 hours before surgery;
- Chronic respiratory disease requiring oxygen therapy or mechanical ventilation at home;
- Undrained pneumothorax or subcutaneous emphysema;
- Intracranial hypertension;
- Patients for which death is deemed imminent and inevitable or patients with an underlying disease process with a life expectancy of less than 3 months;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical power-guided ventilatory strategy1. Tidal volume 7ml/kg PBW and RR titrated for EtCO2 between 40-50mmHg. See calculated Mechanical power:0,049*tidal volume*RR*driving pressure. 2. Set PEEP 15cmH2O and perform recruitment maneuver at 30cmH2O for 20s. Decrease PEEP from 15 by steps of 2cmH2O until the lower level of PEEP minimizing mechanical power. Note mechanical power. Stop maneuver and/or decrease level of PEEP if decrease>20% of cardiac output during the maneuver, when compared to baseline. 3. Repeat this step using 9 ml/kg PBW and choose the optimal tidal volume with lowest mechanical power. During the surgery, adjust RR to maintain EtCO2 between 40-50mmHg, with an inspiratory-to-expiratory time ratio of 1:2 to 1:1, an end-inspiratory pause of 30%, an FiO2 adjusted to maintain SpO2≥94%. Recruitment maneuvers will be performed after intubation, in case of ventilator disconnection, coelioscopy insufflation, change of position, at the end of surgery, or if mechanical power >30%. | Procedure or surgery | Mechanical power-guided ventilatory strategy |
| Standard fixed ventilatory settingsTidal volume 7 ml/kg predicted body weight, calculated according to a predefined formula: 50+0.91 x (centimeters of height - 152.4) for males and 45.5+0.91 x (centimeters of height - 152.4) for females, fixed PEEP between 6 and 8 cmH20, recruitment maneuvers at the discretion of the physician. The respiratory rate will be adjusted to maintain end-tidal partial pressure of CO2 between 30 and 40 mmHg, a target reported to be used by approximately 90% of physicians according to a recent online survey administered to French anesthesiologists via the French Society of Anesthesia \& Intensive Care Medecine (SFAR), which will be published soon, with an inspiratory-to-expiratory time ratio of 1:2 to 1:1, an end-inspiratory pause of 30 %, and an FiO2 adjusted to maintain SpO2 ≥ 94%. Mechanical power will not be measured during the surgery to avoid any modification of the ventilatory setting by the physician in charge. | Procedure or surgery | Control group with standard fixed ventilatory settings |
Primary outcome
Composite of postoperative respiratory failure
Time frame: Up to 12 hours after surgery
Defined as failure to wean from the ventilator within the first 12 hours after surgery
Composite of postoperative respiratory failure
Time frame: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
Defined as the need for unplanned reintubation following the end of surgery, once extubated
Composite of postoperative respiratory failure
Time frame: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
Defined as the need for therapeutic non-invasive ventilation following the end of surgery, once extubated
All-cause mortality
Time frame: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
Defined as death from any cause occurring within 30 days following surgery. The time to death will be measured from the date of surgery to the date of death. Patients discharged from hospital alive before Day 30 or still alive at Day 30 will be considered censored at that time.
12 secondary outcomes
Severity of postoperative pulmonary complications following surgery
Time frame: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
Renal dysfunction following surgery
Time frame: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
Sepsis and septic shock following surgery
Time frame: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
Sepsis-related Organ Failure Assessment (SOFA)
Time frame: At randomization (day 0), at Day 1, at Day 7
Ventilator-free days (VFDs)
Time frame: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
Duration of invasive mechanical ventilation
Time frame: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
Total duration of mechanical ventilation
Time frame: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
Time to successful tracheal extubation
Time frame: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
ICU-free days
Time frame: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
Length of ICU stay
Time frame: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
Length of hospital stay
Time frame: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
Time to death (or censoring)
Time frame: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Audrey DEBRUS, Dr principal investigator
University Hospital, Montpellier
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical power-guided ventilatory strategy and Standard fixed ventilatory settings in people with Postoperative Respiratory Failure and Abdominal Surgery, run by University Hospital, Montpellier.
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 10 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: opening soon, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Audrey DE JONG, Pr (04 67 33 72 71, a-de_jong@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of postoperative respiratory failure (time frame: Up to 12 hours after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jun 2026.