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

Not Applicable

Not yet recruiting

• Conditions: Mechanical Ventilation Complication
• Interventions: Procedure: Peep individualization

• Registration Number: NCT05781373
• Lead Sponsor: Mongi Slim Hospital

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.

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-01
• Study First Submitted QC: 2023-03-11
• Last Update Submitted: 2023-03-11
• Study First Posted: 2023-03-23
• Last Update Posted: 2023-03-23
• Study Start: 2023-04-01
• Primary Completion: 2024-04-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

• unplanned post operative ICU stay and mechanical ventilation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individualized PEEP group	Peep individualization	Protective intraoperative ventilation with: 6 ml/kg IBW tidal volume recruitment maneuver and individualized PEEP¨level in order to achieve the lowest driving pressure

Primary Outcome Measures

Name	Time	Method
incidence of pulmonary post operative complications	first 7 post operative days	SpO2\< 92%, new chest Xray infiltrates, acute respiratory failure requiring intervention

Secondary Outcome Measures

Name	Time	Method
lung aeration score (LAS)	day 1, day 3 and day 7 after surgery	assessment LAS with lung ultrasound minimum 0 maximum: 36 (worse outcome)