PROtective Ventilation With FLOW-Controlled Ventilation
Recruiting
N/AInterventional Study
Postoperative Pulmonary Complications (PPCs)Feasibility StudiesPilot Study
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
100 (estimated)
Sponsor
Cantonal Hospital of St. Gallen · Other
Who this trial is looking for
This trial is looking for patients having robot-assisted laparoscopic surgery to see if a new breathing technique is safer and easier than the current one. Participants will need to agree to follow the study rules and give consent before the surgery.
Are You a Good Fit for This Trial?
You may be able to join if
I am having elective robot-assisted laparoscopic surgery
I am at risk for lung problems after surgery
I am over 40 years old and my surgery will last more than 2 hours
I will have a catheter for blood pressure during surgery
I am at least 18 years old
I can give written consent to participate
You may not be able to join if
My ideal body weight is less than 40 kg
I have severe health issues (ASA score IV-VI)
I have already joined this study before
I am the study investigator or related to one
I am pregnant or lactating
I cannot give informed consent
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 seve…
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.
Trial Locations
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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 s…
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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