N/A
N=111
Nasal Continuous Positive Airway Pressure Versus Standard Care During Procedural Sedation for Gastrointestinal Endoscopy
Hypoxia · Endoscopy · Anesthesia Morbidity
Bottom Line
View on ClinicalTrials.gov: NCT03369197 ↗Enrolled (actual)
111
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Hypoxia Rate as Assessed by Number of Participants With at Least One Hypoxic Event — 3; 16 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nasal Mask (Device); Control: Nasal Cannula (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hypoxia Rate as Assessed by Number of Participants With at Least One Hypoxic Event |
3; 16 | — |
| SECONDARY Hypoventilation in Subjects Undergoing Procedural Sedation for Endoscopy as Assessed by Transcutaneous Carbon Dioxide Monitoring |
53.3; 51.9 | — |
| SECONDARY Hypoventilation in Subjects Undergoing Procedural Sedation for Endoscopy as Assessed by Respiratory Volume Monitoring |
64; 59 | — |
| SECONDARY Mechanism of Hypoventilation in Subjects Undergoing Procedural Sedation for Endoscopy and Hypoventilation |
— | — |
| SECONDARY Depth of Anesthesia in Subjects Undergoing Procedural Sedation for Endoscopy |
40.19; 40.30 | — |
| SECONDARY Hypoxia Duration |
— | — |
| SECONDARY Total Number of Hypoxic Events in Subjects That Experienced Hypoxia |
4; 23 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Adult patients (≥ 18 years of age) undergoing colonoscopy, endoscopic gastroduodenoscopy, and endoscopic gastroduodenoscopy with biopsy and/or ultrasound, or combined upper and lower endoscopy procedure anticipated to last longer than 10 minutes in the Endoscopy Suite at the Johns Hopkins Hospital when the anesthetic plan is monitored anesthesia care with propofol-based anesthesia with a natural airway.
Exclusion Criteria
- Left ventricular Assist Device
- Severe Pulmonary Hypertension
- Ejection fraction less than 35 percent
- Active Congestive Heart Failure Exacerbation
- Planned procedure is Balloon Enteroscopy or Endoscopic Retrograde Duodenoscopy.
- Topical lidocaine administration
- Pregnancy
- Previous enrollment in this study
Data sourced from ClinicalTrials.gov (NCT03369197). 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.