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

NCT ID: NCT05781373

Last Updated: 2023-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-06-30

Brief Summary

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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

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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.

Conditions

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Mechanical Ventilation Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Fixed PEEP group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

Peep individualization

Intervention Type PROCEDURE

Intraoperative Peep individualization in order to achieve the lowest driving pressure

Interventions

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Peep individualization

Intraoperative Peep individualization in order to achieve the lowest driving pressure

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* unplanned post operative ICU stay and mechanical ventilation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mongi Slim Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mhamed Sami Mebazaa

Professor head of anesthesia and intensive care department

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Mhamed Sami Mebazaa, full prof

Role: CONTACT

0021622252589

Asma Ben Souissi, asso prof

Role: CONTACT

0021698336883

Other Identifiers

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individualized Peep

Identifier Type: -

Identifier Source: org_study_id

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