Driving Pressure During General Anesthesia for Open Abdominal Surgery
- Conditions
- Postoperative Respiratory Complication
- Interventions
- Procedure: Individualized high PEEP strategy
- Registration Number
- NCT03884543
- Brief Summary
The purpose of this international multicenter, patient and outcome-assessor blinded randomized controlled trial is to determine whether the application of an individualized high PEEP strategy, aiming at avoiding an increase in the driving pressure during intraoperative ventilation, protects against the development of postoperative pulmonary complications.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1468
- Scheduled for open abdominal surgery
- High or intermediate risk for postoperative pulmonary complications according to ARISCAT score [J.Canet et al, Anesthesiology 2010;113]
- General anesthesia
- Laparoscopic surgery
- Surgery in prone or lateral position
- Combined procedure with open abdominal and intrathoracic surgery
- Body mass index > 40 kg/m2;
- Reported pregnancy;
- Mechanical ventilation > than 30 minutes (e.g., in cases of general anesthesia because of surgery) within last 30 days;
- Any major previous lung surgery;
- History of previous severe chronic obstructive pulmonary disease (COPD) GOLD III or IV, or with (noninvasive) ventilation and/or oxygen therapy at home;
- (previous) acute respiratory distress syndrome (ARDS);
- Expected to require postoperative mechanical ventilation;
- Persistent hemodynamic instability or intractable shock;
- Severe cardiac disease (New York Heart Association class III or IV, or acute coronary syndrome, or persistent ventricular tachyarrhythmia's);
- Consented for another interventional study during anesthesia or refusal to participate in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Individualized high PEEP strategy Individualized high PEEP strategy Recruitment maneuver (performed after induction of anesthesia, after any disconnection from the mechanical ventilator, and before extubation) followed by the decremental PEEP trial to determine the highest level of PEEP resulting in the lowest driving pressure. This is again followed by a recruitment maneuver, after which PEEP is set at the level indicated by the decremental PEEP trial.
- Primary Outcome Measures
Name Time Method Proportion of participants developing one or more postoperative pulmonary complications (PPCs) The first 5 postoperative days Severe respiratory failure; ARDS; Suspected pulmonary infection; Pulmonary infiltrate ; Pleural effusion; Atelectasis; Pneumothorax; Bronchospasm; Aspiration pneumonitis; Cardiopulmonary edema
- Secondary Outcome Measures
Name Time Method Rate of mild respiratory failures The first 5 postoperative days Defined as a PaO2 \< 60 mmHg (or \< 7.9 kPa) or SpO2 \< 90% in room air, but responding to supplemental oxygen (excluding hypoventilation)
Number of participants with an unscheduled Intensive Care Unit (ICU) (re-) admission and length of stay in Intensive care unit From the day of surgery until the day of discharged, up to day 90 Assessment of postoperative wound healing The first 5 postoperative days Visual inspection of the following: impairment of wound healing and/or wound infection;
Rate of intra-operative complications For the length of the anesthesia, which will be estimated 2 to 5 hours. The total amount and type of intraoperative fluid administration For the length of the anesthesia, which will be estimated 2 to 5 hours Type of fluids: colloids, crystalloids or blood products
Proportion of participants developing one or more post-operative extra-pulmonary complications The first 5 postoperative days Including sepsis (according to the SEPSIS-3 definition), septic shock (defined as sepsis with persisting hypotension requiring vasopressors to maintain MAP ≥ 65mmHg and having a serum lactate level \>2 mmol/L despite adequate volume resuscitation), extra-pulmonary infection (including wound infection and any other infection), anastomic leak and acute renal failure (as defined by AKIN \[Mehta RL., et al., Acute Kidney Injury Network: report of an initiative to improve outcomes in acute kidney injury. Crit Care, 2007\])
Rate of all-cause mortality and in-hospital mortality Postoperative day 5, day 30 and day 90 Length of hospital stay From the day of surgery until the day of discharge, up to day 90
Trial Locations
- Locations (22)
Noordwest ziekenhuizengroep Alkmaar
🇳🇱Alkmaar, Netherlands
University hospital Carl Gustav Carus
🇩🇪Dresden, Germany
Heinrich-Heine University Hospital Dusseldorf
🇩🇪Dusseldorf, Germany
Bermanntrost BG Klinikum Halle
🇩🇪Halle, Germany
Ospedale Policlinico San Martino
🇮🇹Genua, Italy
University hospital Napoli
🇮🇹Napoli, Italy
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
🇳🇱Amsterdam, Netherlands
Amsterdam UMC location VUmc
🇳🇱Amsterdam, Netherlands
Haaglanden Medisch Centrum
🇳🇱Den Haag, Netherlands
Onze Lieve Vrouwen Gasthuis
🇳🇱Amsterdam, Netherlands
Rijnstate Hospital
🇳🇱Arnhem, Netherlands
Spaarne Gasthuis Hospital
🇳🇱Haarlem, Netherlands
Radboud UMC
🇳🇱Nijmegen, Netherlands
Erasmus Medisch Centrum
🇳🇱Rotterdam, Netherlands
HAGA
🇳🇱Den Haag, Netherlands
Martini Hospital
🇳🇱Groningen, Netherlands
UMC Groningen
🇳🇱Groningen, Netherlands
Albert Schweitzer Ziekenhuis
🇳🇱Dordrecht, Netherlands
Medical Center Leeuwarden
🇳🇱Leeuwarden, Netherlands
Maastricht UMC
🇳🇱Maastricht, Netherlands
Bernhoven Hospital
🇳🇱Uden, Netherlands
Leiden UMC
🇳🇱Leiden, Netherlands