Novel Technique for Face Mask Ventilation (NCT01946464) | Clinical Trial Compass
TerminatedNot Applicable
Novel Technique for Face Mask Ventilation
United States30 participantsStarted 2012-09
Plain-language summary
This study is being done to see if we can improve the way we manage patients' airways. In some instances patients who have a beard, who do not have teeth or have breathing problems during sleep present a challenge to the anesthesiologist. In such patients, it is sometimes difficult to provide air/oxygen for breathing using a mask. The study doctors would like to investigate a new method for holding a mask on the face of those patients. They are interested in comparing a new method against two older methods. They believe the new method will deliver a larger amount of air to the lungs. This information may help doctors provide better care for patients who have beards, no teeth, or breathing problems during sleep.
Who can participate
Age range
18 Years – 85 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:
* undergoing general anesthesia
* no longer have your own teeth
* have a beard
* have obstructive sleep apnea
* ASA score of 1, 2,3
* BMI\<45
* Mallampati I, II. II or IV -(nil per os) Nothing taken orally for 8 hours-
Exclusion Criteria:
* ASA 4
* Morbidly obese \>45
* Loose teeth
* cervical neck instability
* history of difficult airway
* Pregnancy
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
tidal volume
Timeframe: at induction
Trial details
NCT IDNCT01946464
SponsorRutgers, The State University of New Jersey