Respiration Rate Monitoring During Transitions (NCT01881269) | Clinical Trial Compass
CompletedNot Applicable
Respiration Rate Monitoring During Transitions
United States27 participantsStarted 2013-06
Plain-language summary
The purpose of this study is to evaluate the performance of the software that calculates respiration rate for the study pulse oximetry monitoring system during transitions of ventilation type from spontaneous breathing to controlled ventilation.
Who can participate
Age range
18 Years – 65 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:
* Be undergoing a procedure with planned general anesthesia involving placement of an endotracheal tube or laryngeal mask airway following induction of anesthesia.
* American Society of Anesthesiologists physical status classification (ASA) Status 1, 2 or 3.
* Body mass index (BMI) ≤30 kg/m2.
* Subject is willing and able to provide written consent.
Exclusion Criteria:
* Female subjects of child-bearing potential with a positive pregnancy test or an absence of documented non-childbearing status in the medical history records.
* Female subjects who are currently lactating and breastfeeding.
* Subjects with any evidence of potential difficulty in mask ventilation and/or tracheal intubation.
* Subject has an abnormality that may prevent proper application of the device/sensors.
* Subject is in atrial fibrillation.
* Subject has a documented history of frequent premature ventricular contractions (PVCs), defined as greater than 3 in 30 seconds or greater than 6 in 60 seconds.
* Subject has an implanted pacemaker.
* Subjects with non-sinus rhythm, frequent premature ventricular complexes (\> 5 min), or abnormal PR, QRS, or QT intervals on screening ECG.
* Subjects with artificial finger nails.
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
Time to report a Respiration Rate value after initiation of controlled ventilation
Timeframe: 1 - 3 minutes after the initiation of controlled ventilation