Investigating flow-controlled ventilation during robot-assisted laparoscopic surgery
Official title: PROtective Ventilation With FLOW-Controlled Ventilation to Improve Postoperative Pulmonary Outcome After ROBOT-Assisted Laparoscopic Surgery - an International Multicenter Pilot Randomized Clinical Trial.
Run by Cantonal Hospital of St. Gallen · NCT06703814 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Cantonal Hospital of St. Gallen Academic / other |
| Locations | 3 sites (Innsbruck, Tyrol and 2 other locations) |
| Status | Recruiting |
| Started | August 2, 2025 |
| Main results expected | October 30, 2026 |
| Study ends | November 30, 2026 |
| Registry record updated | October 21, 2026 |
| Trial ID | NCT06703814 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older undergoing elective robot-assisted laparoscopic surgery with an increased risk of postoperative pulmonary complications.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have shown that flow-controlled ventilation is a safe method for patients undergoing surgery, indicating potential for success in this approach.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Automated ABPI for Peripheral Artery Disease: A Pilot Look at Two Devices
This pilot checks if two automated ankle-brachial pressure index devices can reliably detect PAD across symptom levels and after bypass surgery, using patient and clinician feedback for practicality.
-
AI-powered personalized exercise plan for older adults using a wearable app
A wearable-enabled, AI-driven exercise app is tested to see if it’s feasible and acceptable for adults 65+ and whether it can help increase activity, improve mood, and boost quality of life.
-
Early breathing therapy just one hour after CABG extubation
This trial tests whether starting respiratory physiotherapy one hour after extubation improves recovery for adults after elective CABG compared with starting on the first postoperative day.
-
Timing of Recruitment Maneuver in Robotic Prostate Surgery
This study tests whether doing a recruitment maneuver before or after CO2 insufflation during robotic prostate surgery helps prevent lung problems afterward.
-
Behavioral program to help depressed nursing home residents see if it helps
This study tests the InSTILL program to see if it is feasible, satisfactory, and helpful for residents of skilled nursing facilities who have depressive symptoms.
-
Early pregnancy lifestyle patterns and glucose changes in a TOFFFY sub-study
This study tests whether daily patterns like sleep, activity, and meal timing in early pregnancy affect glucose levels and the risk of gestational diabetes, using CGM and wearable data in pregnant women in Singapore.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.