Driving Pressure During General Anesthesia for Minimally Invasive Abdominal Surgery (GENERATOR)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status: Enrolling

Conditions: Postoperative Complications; Surgery

Treatments: Procedure: Intraoperative ventilation with individualized high PEEP titrated to the lowest ΔP with RMs

Study type: Interventional

Funder types: Other

Identifiers

NCT06101511

NL82971.018.23

Details and patient eligibility

About

The purpose of this international multicenter, patient and outcome-assessor blinded randomized controlled trial is to determine whether the application of an individualized high Positive End Expiratory Pressure (PEEP) strategy with recruitment maneuvers, aiming at avoiding an increase in the driving pressure during intraoperative ventilation, protects against the development of postoperative pulmonary complications in patients undergoing minimally invasive abdominal surgery.

Enrollment: 1,806 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. age > 18 years; AND
2. scheduled for minimally invasive abdominal surgery; AND
3. at increased (i.e., intermediate or high) risk of PPCs according to the 'Assess Respiratory risk in Surgical Patients in Catalonia' (ARISCAT) risk score (≥ 26 points, see Appendix I); OR at increased risk of PPCs based on the combination of age > 40 years, scheduled surgery lasting > 2 hours and planned to receive an intra-arterial catheter for blood pressure monitoring during the surgery; AND
4. signed written informed consent

Exclusion criteria

1. planned for open abdominal surgery;
2. planned for surgery in lateral or prone position;
3. planned for combined abdominal and intra-thoracic surgery
4. confirmed pregnancy;
5. consent for another interventional trial during anesthesia;
6. having received invasive ventilation > 30 minutes within the last five days;
7. any previous lung surgery;
8. history of previous severe chronic obstructive pulmonary disease (COPD) with (noninvasive) ventilation or oxygen therapy at home or repeated systemic corticosteroid therapy for acute exacerbations of COPD;
9. history of acute respiratory distress syndrome (ARDS);
10. expected to require postoperative ventilation;
11. expected hemodynamic instability or intractable shock;
12. severe cardiac disease (New York Heart Association class III or IV, acute coronary syndrome or persistent ventricular tachyarrhythmia's).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,806 participants in 2 patient groups

Individualized high PEEP strategy with recruitment maneuvers

Experimental group

Description:

The intervention is intraoperative ventilation using the available ventilator with individualized high positive end-expiratory pressure (PEEP) titrated to the lowest driving pressure (ΔP) with recruitment maneuvers (RMs). After abdominal insufflation, patients randomized to the individualized high PEEP with RMs group will receive a RM followed by a 'decremental PEEP trial'. This is followed by a second RM after which PEEP is set at the level indicated by the decremental PEEP trial.

Treatment:

Procedure: Intraoperative ventilation with individualized high PEEP titrated to the lowest ΔP with RMs

Standard low PEEP strategy without recruitment maneuvers

No Intervention group

Description:

Patients randomized to the standard low PEEP group will receive 5 cm H2O PEEP for the complete duration of general anesthesia. They will neither receive one of the planned RMs nor a decremental PEEP trial.