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NCT05781373 Clinical Trial

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

Mechanical Ventilation Complication Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05781373
Other study ID # individualized Peep
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 1, 2023
Est. completion date June 30, 2024

Study information
Verified date March 2023
Source Mongi Slim Hospital
Contact Mhamed Sami Mebazaa, full prof
Phone 0021622252589
Email msmebazaa@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date June 30, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

  • Mechanical Ventilation Complication

Intervention

Procedure:
• Peep individualization
Intraoperative Peep individualization in order to achieve the lowest driving pressure

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Mongi Slim Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary incidence of pulmonary post operative complications SpO2< 92%, new chest Xray infiltrates, acute respiratory failure requiring intervention first 7 post operative days
Secondary lung aeration score (LAS) assessment LAS with lung ultrasound minimum 0 maximum: 36 (worse outcome) day 1, day 3 and day 7 after surgery
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