N/A
Completed N=29
Electric Blower Based Ventilator Used During Procedural Sedation
Apnea During Procedural Sedation
Source: ClinicalTrials.gov NCT02621463 ↗
Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcomePrimary: Percentage of Time the Patient Will Experience Apnea — 11 % time in apnea of total study duration
Summary
Conduct human trials in the endoscopy suite of our continuous positive airway pressure (CPAP) ventilator approach using an FDA approved ventilator.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Time the Patient Will Experience Apnea |
11 | — |
Eligibility Criteria
Inclusion Criteria
- > 18 years of age
- undergoing a colonoscopy procedure
- receiving registered nurse-administered procedural sedation at the University of Utah Health Sciences Center
- agree to participate
- written informed consent
Exclusion Criteria
- Inability/refusal of subject to provide informed consent.
- Standard colonoscopy exclusion criteria used at the GI lab at the University of Utah.
- Pregnant patients and patients with an ASA (American Society of Anesthesiology) physical status of IV or V.
- Patients with severe medical condition(s) that in the view of the acting physician prohibits participation in the study.
- Patients with a BMI > 35 will not be included in the study
Data sourced from ClinicalTrials.gov (NCT02621463). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.