Actively Recruiting
Protective Ventilation With Flow-Controlled Ventilation to Improve Postoperative Pulmonary Outcome After Robot-Assisted Laparoscopic Surgery - An International Multicenter Pilot Randomized Clinical Trial
Led by Cantonal Hospital of St. Gallen · Updated on 2026-04-21
100
Participants Needed
3
Research Sites
4 weeks
Total Duration
On this page
Sponsors
C
Cantonal Hospital of St. Gallen
Lead Sponsor
U
University Hospital Bergmannsheil Bochum
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and feasibility of flow-controlled ventilation (FCV) compared to pressure-controlled ventilation (PCV) in patients undergoing robot-assisted laparoscopic abdominal, urologic, or gynecologic surgery. These surgeries require general anesthesia and mechanical ventilation, which can be challenging and may lead to lung complications. This trial aims to see if FCV is safer and easier to use than current ventilation methods and if it can reduce lung-related problems after surgery. The study compares two ventilation methods during surgery: FCV, which provides a constant airflow during both breathing in and out phases, and PCV, the standard method that controls pressure to achieve a set tidal volume. In FCV, ventilator settings are adjusted based on lung compliance without recruitment maneuvers, while PCV settings include pressure adjustments to maintain oxygen levels and tidal volume based on predicted body weight. Both methods use CE-marked medical ventilators according to manufacturer instructions. Participants will be monitored during surgery and up to seven days afterward to assess safety through gas exchange measurements, ventilator settings, respiratory and hemodynamic complications. The study will also evaluate how well the FCV method is followed and its feasibility. Outcomes include detailed lung function tests, respiratory complications, and recovery markers. Data will be collected through clinical assessments and electronic case report forms, with a total participation involving intraoperative care and postoperative follow-up.
CONDITIONS
Brief Title
PROtective Ventilation With FLOW-Controlled Ventilation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Undergoing elective robot-assisted laparoscopic surgery in supine or Trendelenburg position (abdominal, urologic, or gynecologic surgery)
- Increased risk of postoperative pulmonary complications according to ARISCAT risk score (26 points or higher)
- Or combination of age over 40 years, scheduled surgery lasting more than 2 hours, and planned intra-arterial catheter for blood pressure monitoring
- Aged 18 years or older
- Able to provide written informed consent and comply with the study protocol
You will not qualify if you...
- Ideal body weight less than 40 kg
- ASA Physical Status Classification System score IV to VI
- Previous enrollment in this study
- Being the study investigator, their family members, employees, or other dependent persons
- Known pregnancy, positive pregnancy test, or lactating if female and of childbearing potential
- No written informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 hours during surgery and mechanical ventilation
Participants undergo robot-assisted laparoscopic surgery under general anesthesia and receive intraoperative ventilation using either flow-controlled ventilation (FCV) or pressure-controlled ventilation (PCV) as assigned by randomization.
1 surgical visit (in-person)
Duration - Up to 7 days post-surgery
Participants are monitored for postoperative pulmonary complications and study outcomes for up to 7 days after surgery or until hospital discharge, whichever comes first.
Daily visits or assessments during hospitalization for up to 7 days
Trial Site Locations
Total: 3 locations
1
Department of Anaesthesiology, Medical University Innsbruck
Innsbruck, Tyrol, Austria, 6020
Actively Recruiting
2
Department of Anesthesiology, Intensive Care and Pain Medicine, BG University Hospital Bergmannsheil, Ruhr-University Bochum, Germany
Bochum, Germany, Germany, 44789
Completed
3
Department of Anaesthesiology, Rescue- and Pain Medicine Cantonal Hospital St. Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland, 9000
Completed
Research Team
T
Timur Yurttas, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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