PROtective Ventilation With FLOW-Controlled Ventilation to Improve Postoperative Pulmonary Outcome After ROBOT-Assisted Laparoscopic Surgery - an International Multicenter Pilot Randomized Clinical Trial.

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Germany
Department of Anesthesiology, Intensive Care and Pain Medicine, BG University Hospital Bergmannsheil, Ruhr-University Bochum, Germany
RECRUITING
Bochum
Netherlands
Department of Anesthesiology, Amsterdam UMC
NOT_YET_RECRUITING
Amsterdam
Switzerland
Department of Anesthesiology, Cantonal Hospital Luzern
NOT_YET_RECRUITING
Lucerne
Department of Anaesthesiology, Rescue- and Pain Medicine Cantonal Hospital St. Gallen
RECRUITING
Sankt Gallen
Contact Information
Primary
Timur Yurttas, MD
proflow@kssg.ch
+41714949158
Time Frame
Start Date: 2025-02-02
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 100
Treatments
Experimental: Intraoperative flow-controlled ventilation FCV
Flow-controlled ventilation (FCV) differs from conventional ventilation modes in several key ways. Unlike pressure-controlled ventilation (PCV) and volume-controlled ventilation (VCV), FCV maintains a constant airflow during both the inspiration and expiration phases. This method generates smooth linear pressure variations by delivering a constant positive flow during inspiration and a constant negative flow during expiration, resulting in linearly changing airway pressures. Additionally, FCV operates without any interruptions in flow throughout the cycle. This consistent rate of pressure and volume change in the lungs, particularly the linear decrease in airway pressure during expiration, has been shown to improve lung recruitment. This approach may thus reduce the risk of pulmonary complications commonly associated with conventional ventilation modes.
Active_comparator: Intraoperative pressure-controlled ventilation PCV
Pressure-controlled ventilation (PCV) is the standard of care in patients undergoing mechanical ventilation during general anesthesia in robot-assisted laparoscopic surgery. The operator sets the inspiratory pressure (rather than tidal volume as in VCV) and respiratory rate (along with FiO2, I:E ratio and PEEP). Typically, the pressure is titrated to achieve a targeted tidal volume.
Related Therapeutic Areas
Sponsors
Leads: Cantonal Hospital of St. Gallen
Collaborators: Luzerner Kantonsspital, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), University Hospital Bergmannsheil Bochum

This content was sourced from clinicaltrials.gov