Supraglottic Jet Oxygenation and Ventilation (SJOV) for Hypoxemia During Deep Sedation for Gastrointestinal Endoscopy at High-altitude
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Hypoxia during sedation
Study Overview
Brief Summary
This study aims to determine whether the use of SOJV could reduce the rate of hypoxia during gastrointestinal endoscopic procedures in deeply sedated patients sedated at high altitude comparing to the supplemental oxygen administration via nasal cannula.
Detailed Description
The participants will be randomly allocated to either SJOV or nasal cannula oxygen supply in a 1:1 ratio using block randomization with variable block sizes of four or six randomized. In the nasal cannula oxygen supply group, oxygen supplementation at 2 liters min-1 is delivered via a nasal cannula. In the SJOV group, SJOV is conducted using a Wei nasal jet tube (WNJ, Well Lead Medical Co. Ltd, Guangzhou, China) which is connected to a manual jet ventilator (Well Lead Medical Co. Ltd, Guangzhou, China) via its jet port.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •18 years or older;
- •underwent routine gastrointestinal endoscopy under procedural sedation;
- •consented to participate in this trial. -
Exclusion Criteria
- •infection of the upper airway;
- •anatomical abnormalities of the face, nose, and upper airway;
- •coagulopathies;
- •anticipated or known difficult airway;
- •known allergy against propofol, soybeans, and egg;
- •absence from the high-altitude environment during the past 3 months. -
Arms & Interventions
Supraglottic jet oxygenation and ventilation
Supraglottic jet oxygenation and ventilation is conducted for the participants during sedation.
Intervention: Supraglottic jet oxygenation and ventilation (Procedure)
nasal cannula oxygen supply
Oxygen supplementation is delivered via a nasal cannula to the participants during sedation.
Intervention: Nasal cannula oxygen supply (Procedure)
Outcomes
Primary Outcomes
Hypoxia during sedation
Time Frame: During sedation procedure
An SPO2 of 75 - 89% for \< 60 s
Secondary Outcomes
- respiratory-related complications(During sedation procedure)
- cardiovascular-related complications(During sedation procedure)
- fatal complications(from sedation initiation to 20 min after patients are awake)
Investigators
Yi Feng, MD
Chair of Department of Anesthesiology
Peking University People's Hospital