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

NCT05781373 | Unknown

• 1 other identifier: individualized Peep
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mechanical Ventilation Complication

Outcome Measures

Primary Outcomes (1)

• incidence of pulmonary post operative complications

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

  first 7 post operative days

Secondary Outcomes (1)

• lung aeration score (LAS)

  day 1, day 3 and day 7 after surgery

Study Arms (2)

Fixed PEEP group

NO INTERVENTION

Protective intraoperative ventilation with: 6 ml/kg IBW tidal volume recruitment maneuver and fixed PEEP¨level of 6 cmH2O

Individualized PEEP group

EXPERIMENTAL

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

Interventions

Peep individualization PROCEDURE

Intraoperative Peep individualization in order to achieve the lowest driving pressure

Individualized PEEP group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• unplanned post operative ICU stay and mechanical ventilation

Sponsors & Collaborators

• Mongi Slim Hospital: lead

Central Study Contacts

Mhamed Sami Mebazaa, full prof

CONTACT

0021622252589; msmebazaa@gmail.com

Asma Ben Souissi, asso prof

CONTACT

0021698336883; bsouissiasma@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor head of anesthesia and intensive care department

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 23, 2023
• Study Start: April 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: June 30, 2024
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share