CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 111 enrolled
Drug / intervention
Nasal Mask +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03369197
NCT03369197N/ACompleted
CompareCT.gov

A Randomized Controlled Trial of an Intervention to Reduce the Incidence of Hypoxia With Nasal Continuous Positive Airway Pressure Versus Standard Care During Procedural Sedation for Gastrointestinal Endoscopy

Johns Hopkins University·interventional·Posted Dec 11, 2017·Updated Oct 18, 2022

In Brief

A clinical study evaluating Nasal Mask and Control: Nasal Cannula for Hypoxia and 2 related conditions. Completed, enrolled 111 participants across 1 site.

Detailed Summary

This study is a randomized controlled trial comparing oxygen delivery by nasal mask with continuous positive airway pressure versus standard care (nasal cannula or standard facemask) during propofol-based sedation for gastrointestinal endoscopy procedures to reduce the incidence of hypoxia. The primary outcome will be the rate of oxygen desaturation below 90% for ≥15 seconds.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypoxia, Endoscopy, Anesthesia Morbidity
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedDec 11, 2017
Enrollment StartOct 30, 2017
Primary CompletionOct 23, 2019
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 8.6 years ago

Interventions

Nasal Maskdevice

Nasal anesthesia mask which covers the nose and attaches to the anesthesia circuit, allowing for variable positive pressure by setting the pop-off valve

Control: Nasal Cannuladevice

Nasal cannula as per usual care