Effect of Applying Cuff Air Leak Pressure as Intraoperative Cuff Pressure on Postoperative Compli… (NCT04302142) | Clinical Trial Compass
WithdrawnNot Applicable
Effect of Applying Cuff Air Leak Pressure as Intraoperative Cuff Pressure on Postoperative Complications
Stopped: The study was stopped due to COVID restrictions on staff, therefore enrollment was not started.
United States0Started 2021-06
Plain-language summary
The purpose of the study is to achieve effective ventilation with critical intracuff pressure (Pcr) and determine if application of Pcr reduces the risks associated with over-insufflation of endotracheal cuff including postoperative sore throat, cough,nausea, vomiting, aspiration, and pneumonia.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Elective Surgery under general anesthesia requiring endotracheal tube with mechanical ventilation and expected anesthesia duration of at least 2 hours.
* No contra-indication for intra-operative volume controlled mechanical ventilation
* Flat supine surgeries without expected positional adjustments
* American Society of Anesthesiologists (ASA) physical status I-III
Exclusion Criteria:
* Use of Nitrous Oxide
* BMI \> 40
* Ventilation through Nasal intubation or Tracheostomy
* Preexisting sore throat, coughing, nausea/vomiting
* Recent history of upper respiratory infection
* Pregnancy
* Expected to be kept intubated after surgery completion
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Minimum intracuff pressure at which there is no air leak around the cuff.
Timeframe: during surgery
Trial details
NCT IDNCT04302142
SponsorThe University of Texas Health Science Center, Houston