N/A N=29 Supportive Care

Electric Blower Based Ventilator Used During Procedural Sedation

Apnea During Procedural Sedation

Bottom Line

View on ClinicalTrials.gov: NCT02621463 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2021

Primary outcome: Primary: Percentage of Time the Patient Will Experience Apnea — 11 % time in apnea of total study duration

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Noninvasive Ventilator (V60, Philips) (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Utah
Primary completion: Jun 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Time the Patient Will Experience Apnea	11	—

Summary

Conduct human trials in the endoscopy suite of our continuous positive airway pressure (CPAP) ventilator approach using an FDA approved ventilator.

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

View full record on ClinicalTrials.gov →

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.