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

Mongi Slim Hospital

Status: Not yet enrolling

Conditions: Mechanical Ventilation Complication

Treatments: Procedure: Peep individualization

Study type: Interventional

Funder types: Other

Identifiers

NCT05781373

individualized Peep

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• unplanned post operative ICU stay and mechanical ventilation

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Fixed PEEP group

No Intervention group

Description:

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

Individualized PEEP group

Experimental group

Description:

Protective intraoperative ventilation with: 6 ml/kg IBW tidal volume recruitment maneuver and individualized PEEP¨level in order to achieve the lowest driving pressure

Treatment:

Procedure: Peep individualization