CompletedNot Applicable

Nasal Continuous Positive Airway Pressure Versus Standard Care During Procedural Sedation for Gastrointestinal Endoscopy

United States111 participantsStarted 2017-10-30

Plain-language 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.

Who can participate

Age range18 Years – 100 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Hypoxia Rate as Assessed by Number of Participants With at Least One Hypoxic Event

Timeframe: Approximately 1 hour

Trial details

NCT IDNCT03369197

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-10-23

Results submitted2020-10-22

View on ClinicalTrials.gov More Hypoxia trials