NCT06703814 PROtective Ventilation With FLOW-Controlled Ventilation
| NCT ID | NCT06703814 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cantonal Hospital of St. Gallen |
| Condition | Postoperative Pulmonary Complications (PPCs) |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-08-02 |
| Primary Completion | 2026-04-30 |
Trial Parameters
Eligibility Fast-Check
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Brief 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.
Eligibility 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 posit