Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06703814

PROtective Ventilation With FLOW-Controlled Ventilation

Led by Cantonal Hospital of St. Gallen · Updated on 2026-04-21

100

Participants Needed

3

Research Sites

43 weeks

Total Duration

On this page

Sponsors

C

Cantonal Hospital of St. Gallen

Lead Sponsor

U

University Hospital Bergmannsheil Bochum

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

PROtective Ventilation With FLOW-Controlled Ventilation

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 3 locations

1

Department of Anaesthesiology, Medical University Innsbruck

Innsbruck, Tyrol, Austria, 6020

Actively Recruiting

2

Department of Anesthesiology, Intensive Care and Pain Medicine, BG University Hospital Bergmannsheil, Ruhr-University Bochum, Germany

Bochum, Germany, Germany, 44789

Completed

3

Department of Anaesthesiology, Rescue- and Pain Medicine Cantonal Hospital St. Gallen

Sankt Gallen, Canton of St. Gallen, Switzerland, 9000

Completed

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Research Team

T

Timur Yurttas, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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PROtective Ventilation With FLOW-Controlled Ventilation | DecenTrialz