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

• Sponsor: Mongi Slim Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05781373
• Collaborator: (none)
• Enrollment: 100
• Arms: 2
• Anticipated Duration (Months): 15

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mechanical Ventilation Complication	Procedure: Peep individualization	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Effect of Intraoperative PEEP Individualization According to Driving Pressure in Major Abdominal Surgery
• Anticipated Study Start Date: Apr 1, 2023
• Anticipated Primary Completion Date: Apr 30, 2024
• Anticipated Study Completion Date: Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Fixed PEEP group Protective intraoperative ventilation with: 6 ml/kg IBW tidal volume recruitment maneuver and fixed PEEP¨level of 6 cmH2O
Experimental: Individualized PEEP group Protective intraoperative ventilation with: 6 ml/kg IBW tidal volume recruitment maneuver and individualized PEEP¨level in order to achieve the lowest driving pressure	Procedure: Peep individualization; Intraoperative Peep individualization in order to achieve the lowest driving pressure

Outcome Measures

Primary Outcome Measures

1. 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

1. lung aeration score (LAS) [day 1, day 3 and day 7 after surgery]

   assessment LAS with lung ultrasound minimum 0 maximum: 36 (worse outcome)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• unplanned post operative ICU stay and mechanical ventilation

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Mongi Slim Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mhamed Sami Mebazaa, Professor head of anesthesia and intensive care department, Mongi Slim Hospital
• ClinicalTrials.gov Identifier: NCT05781373
• Other Study ID Numbers: individualized Peep
• First Posted: Mar 23, 2023
• Last Update Posted: Mar 23, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 23, 2023