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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

Eligibility

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).

Study details
    Postoperative Complications
    Surgery

NCT06101511

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

29 January 2024

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