Mechanical Power for Ventilatory Settings in Operating Room

NCT07620132 | Not Yet Recruiting

• 1 other identifier: RECHMPL24_0492
• Study Type: interventional
• Target: 490
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

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

Outcome Measures

Primary Outcomes (4)

• Composite of postoperative respiratory failure

  Defined as failure to wean from the ventilator within the first 12 hours after surgery

  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

  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

  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.

  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

  Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30

• Renal dysfunction following surgery

  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

  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)

  At randomization (day 0), at Day 1, at Day 7

• Ventilator-free days (VFDs)

  Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30

Other Outcomes (13)

• Postoperative hypoxemia

  Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30

• Postoperative pneumonia

  Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30

• Acute Respiratory Distress Syndrome (ARDS)

  Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30

Study Arms (2)

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.

Procedure: Mechanical power-guided ventilatory strategy

Control group with standard fixed ventilatory settings

ACTIVE COMPARATOR

In the control group, standard care will be performed.

Procedure: Standard fixed ventilatory settings

Interventions

Mechanical power-guided ventilatory strategy PROCEDURE

1. 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%.

Mechanical power-guided ventilatory strategy

Standard fixed ventilatory settings PROCEDURE

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.

Control group with standard fixed ventilatory settings

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)
• Laparoscopic or non-laparoscopic abdominal surgery
• With an expected duration of at least 2 hours

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Officials

• Audrey DEBRUS, Dr

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Audrey DE JONG, Pr

CONTACT

04 67 33 72 71; a-de_jong@chu-montpellier.fr

Samir JABER, Pr

CONTACT

04 67 33 72 71; s-jaber@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Blinding of the surgical team is not feasible due to the nature of the intervention (surgery). However, participants and outcome assessors responsible for evaluating study endpoints will remain blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: June 2, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: June 2, 2026

Record last verified: 2026-05