Investigating flow-controlled ventilation during robot-assisted laparoscopic surgery
PROtective Ventilation With FLOW-Controlled Ventilation to Improve Postoperative Pulmonary Outcome After ROBOT-Assisted Laparoscopic Surgery - an International Multicenter Pilot Randomized Clinical Trial.
This study is testing if a new way of helping patients breathe during robot-assisted surgery can make it safer for those at risk of lung problems after the operation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cantonal Hospital of St. Gallen Academic / other |
| Locations | 3 sites (Innsbruck, Tyrol and 2 other locations) |
| Trial ID | NCT06703814 on ClinicalTrials.gov |
What this trial studies
This pilot trial aims to evaluate the safety and feasibility of flow-controlled ventilation (FCV) compared to pressure-controlled ventilation (PCV) in patients undergoing robot-assisted laparoscopic surgery. The study focuses on patients at increased risk for postoperative pulmonary complications (PPCs) and will assess the impact of FCV on lung-specific outcomes during and after surgery. By optimizing intraoperative ventilation strategies, the trial seeks to reduce the incidence of complications associated with mechanical ventilation. The findings will inform the design of a larger trial to test the efficacy of FCV in improving postoperative outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older undergoing elective robot-assisted laparoscopic surgery with an increased risk of postoperative pulmonary complications.
Not a fit: Patients with a body weight under 40 kg or those classified as ASA Physical Status IV to VI may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer ventilation techniques and reduced risk of lung complications for patients undergoing major surgery.
How similar studies have performed: Previous studies have shown that flow-controlled ventilation is a safe method for patients undergoing surgery, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * undergoing elective robot-assisted laparoscopic surgery in supine or Trendelenburg position (either abdominal, urologic or gynecologic surgery); * AND increased risk of PPCs according to the ARISCAT risk score (≥ 26 points); * OR 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; * aged ≥ 18 years; and * able to give written informed consent to participate in the study and agree to comply with the study protocol prior to initiation of any study-mandated procedure and study intervention. Exclusion Criteria: * ideal body weight \< 40 kg; * ASA Physical Status Classification System score IV - VI; * previous enrolment into the current study; * being the study investigator, his/her family members, employees and other dependent persons; * if female and of childbearing potential, known pregnancy or a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating; or * No informed consent
Where this trial is running
Innsbruck, Tyrol and 2 other locations
- Department of Anaesthesiology, Medical University Innsbruck — Innsbruck, Tyrol, Austria (Recruiting)
- Department of Anesthesiology, Intensive Care and Pain Medicine, BG University Hospital Bergmannsheil, Ruhr-University Bochum, Germany — Bochum, Germany, Germany (Completed)
- Department of Anaesthesiology, Rescue- and Pain Medicine Cantonal Hospital St. Gallen — Sankt Gallen, Canton of St. Gallen, Switzerland (Completed)
Study contacts
- Principal investigator: Timur Yurttas, MD — Department of Anesthesiology, Rescue- and Painmedicine, Cantonal Hospital St. Gallen, Switzerland
- Study coordinator: Timur Yurttas, MD
- Email: proflow@kssg.ch
- Phone: +41714949158
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.