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PROtective Ventilation With FLOW-Controlled Ventilation

RecruitingNAAges 18 Years - anyAllCantonal Hospital of St. Gallen
NCT06703814 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Intraoperative flow-controlled ventilation strategy
  • Intraoperative pressure-controlled ventilation strategy
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Where

3 sites
Department of Anaesthesiology, Medical University Innsbruck
Innsbruck, Austria
Department of Anesthesiology, Intensive Care and Pain Medicine, BG University Hospital Bergmannsheil, Ruhr-University Bochum, Germany
Bochum, Germany
Department of Anaesthesiology, Rescue- and Pain Medicine Cantonal Hospital St. Gallen
Sankt Gallen, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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