Clinical Trial

PROtective Ventilation With FLOW-Controlled Ventilation

Study acronym: PROFLOW
Recruiting
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Record status
This record was last updated April 21, 2026 (before its estimated April 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
The investigators want to investigate in patients undergoing robot-assisted laparoscopic surgery (a minimally invasive procedure) how applicable flow-controlled ventilation is, and whether it might also be safer than the current ventilation techniques, as well as its impact on potentially reducing the risk of lung-specific complications. Flow-controlled ventilation has already been tested in several studies on animals and humans and has proven to be a safe form of ventilation for patients undergoing surgery under general anesthesia. When patients undergo major surgery, general anesthesia is required and, as a result, mechanical ventilation of the lungs. Especially in long and complex surgeries, ventilation can become more difficult or lead to complications postoperatively. These patients may then experience shortness of breath, coughing, or require medication to improve lung function. In some cases, reintubation or additional mechanical ventilation may be necessary for support. Previous human studies have shown that flow-controlled ventilation is less stressful and, therefore, potentially safer for the lungs compared to traditional ventilation techniques, and that less supplemental oxygen is required. This effect and the safety of flow-controlled ventilation have been demonstrated in several studies. Therefore, in this study, the investigators aim to explore whether flow-controlled ventilation is potentially safer and easier to apply than traditional ventilation techniques and whether it can reduce the risk of lung-specific complications following robot-assisted surgeries, thereby improving the recovery process postoperatively.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-11-21; most recent amendment 2026-04-16.
Status change: Not Yet Recruiting → Recruiting 2025-04-19
Trial Details
NCT Number NCT06703814
Lead Sponsor Cantonal Hospital of St. Gallen
Collaborators: University Hospital Bergmannsheil Bochum, Medical University Innsbruck
Conditions Postoperative Pulmonary Complications (PPCs), Feasibility Studies, Pilot Study
Enrollment 100 participants
Start Date 2025-08-02
Primary Completion 2026-04-30 (estimated)
Study Completion 2026-05-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-21