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Clinical Trials/NCT05781373
NCT05781373
Not yet recruiting
Not Applicable

Effect of Intraoperative PEEP Individualization According to Driving Pressure in Major Abdominal Surgery

Mongi Slim Hospital0 sites100 target enrollmentApril 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mechanical Ventilation Complication
Sponsor
Mongi Slim Hospital
Enrollment
100
Primary Endpoint
incidence of pulmonary post operative complications
Status
Not yet recruiting
Last Updated
3 years ago

Overview

Brief Summary

In this prospective, randomized trial, including patients scheduled for a major open or laparoscopic abdominal surgery (duration >2 hours) under general anesthesia , the investigators will compare 2 strategies of protective mechanical ventilation: a fixed intraoperative PEEP of 6 cmH2O and an individualized intraoperative PEEP according to the driving pressure.

Detailed Description

Patients will be randomized into 2 groups: * Fixed PEEP group: will receive protective intraoperative mechanical ventilation: tidal volume: 6 ml/kg of PBW, recruitment maneuvers every immediately after tracheal intubation and every 2 hours and a fixed PEEP of 6 cmH2O * Individualized PEEP: protective mechanical ventilation with the same modality with an individualization of PEEP levels hourly in order to achieve the lowest driving pressure. PEEP levels will be adjusted after intubation and hourly by increasing or decreasing PEEP levels every 10 respiratory cycles. The primary outcome: incidence of post operative pulmonary complications during the first post operative days.

Registry
clinicaltrials.gov
Start Date
April 1, 2023
End Date
June 30, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mhamed Sami Mebazaa

Professor head of anesthesia and intensive care department

Mongi Slim Hospital

Eligibility Criteria

Inclusion Criteria

  • BMI\<35, ARISCAT score \> 26, patients scheduled for major abdominal surgery

Exclusion Criteria

  • unplanned post operative ICU stay and mechanical ventilation

Outcomes

Primary Outcomes

incidence of pulmonary post operative complications

Time Frame: first 7 post operative days

SpO2\< 92%, new chest Xray infiltrates, acute respiratory failure requiring intervention

Secondary Outcomes

  • lung aeration score (LAS)(day 1, day 3 and day 7 after surgery)

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