Intraoperative Protective Mechanical Ventilation in Patients Requiring Emergency Abdominal Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

707 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-18

Study Completion Date

2022-10-27

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Emergency Abdominal Surgery Mechanical Ventilation General Anesthesia Postoperative Morbidity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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)

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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Low PEEP group

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

Group Type ACTIVE_COMPARATOR

Low PEEP

Intervention Type OTHER

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

Driving-pressure-guided group

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 Type EXPERIMENTAL

Driving-pressure-guided group

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No