An interventional study of Intraoperative ventilation with individualized high PEEP titrated to the lowest ΔP with RMs in Postoperative Complications and Surgery, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Recruiting at 1 site in Netherlands. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-01-30.
Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Not applicable, Interventional, and Treatment
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.
1,267 studies on the registry are indexed under Postoperative Complications; 299 are open to participants now.
This study's planned enrollment of 1,806 is above the median of 117 across 710 interventional studies indexed under Postoperative Complications.
Browse Postoperative Complications studies →Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 532 studies on the registry; 185 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
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.
Procedure: Intraoperative ventilation with individualized high PEEP titrated to the lowest ΔP with RMs
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.
The intervention is intraoperative ventilation using the available ventilator with individualized high PEEP titrated to the lowest ΔP with 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
Also known as: Individualized high PEEP strategy with recruitment maneuvers
Proportion of participants developing one or more postoperative pulmonary complications (PPCs)
A composite of the following pulmonary complications: mild respiratory failure; severe respiratory failure; bronchospasm; suspected pulmonary infection; pulmonary infiltrate; aspiration pneumonitis; atelectasis; acute respiratory distress syndrome (ARDS); pleural effusion; cardiopulmonary edema; pneumothorax
Time frame: The first 5 postoperative days
Intraoperative complications
Including: any episode of desaturation; any episode of hypotension; any need for vasoactive agents, either as bolus or continuous administration, defined as more than needed to compensate for vasodilating effects of anesthesia as judged by the attending anesthesiologist and any new arrhythmias needing intervention
Time frame: For the duration of general anesthesia, these outcomes are scored every hour up to a maximum of 18 hours
Intraoperative fluid strategy
Including the total amount of fluids administered during anesthesia, including the amounts of colloids, crystalloids, and blood products
Time frame: During general anesthesia
Impaired wound healing
Impaired wound healing, as judged and mentioned in the medical record by the attending ward physician;
Time frame: The first 5 postoperative days
Postoperative extrapulmonary complications
Including: sepsis; septic shock; extrapulmonary infection; anastomotic leak and acute renal failure
Time frame: The first 5 postoperative days
Mortality
All-cause mortality at day 5, day 30 and 90, and in-hospital mortality
Time frame: Postoperative day 5, day 30 and day 90
Length of stay
Length of hospital stay (days); length of ICU admission if applicable (days);
Time frame: Postoperatively until the end of the 90 day follow-up period
Oxygen use
Postoperative supplemental oxygen use (days). Presence, duration and levels of postoperative supplemental oxygen
Time frame: The first 5 postoperative days
Antibiotics use
Use of antibiotics for pneumonia (proportion of patients who received antibiotics)
Time frame: The first 5 postoperative days
Thoracic imaging
Occurence of imaging (chest X-ray, computed tomography scan). Proportion of patients who underwent thoracic imaging.
Time frame: The first 5 postoperative days
Plan to share: Yes — Interested researchers can contact the Principal Investigator for a collaboration after which an agreement will be discussed.
Supporting information: Study protocol
Time frame: After the main paper has been published. No end-date has been specified for now.
Access criteria: The applicable researcher can contact the Principal investigator with their idea of using the data, preferably accompanied by a statistical analysis plan
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) →