SJOV vs. HFNO for Hypoxia During Procedural Sedation at High Altitudes
Hypoxemia During Deep Sedation for Gastrointestinal Endoscopy at High Altitudes: High-flow Nasal Oxygen Therapy vs. Supraglottic Jet Oxygenation and Ventilation
1 other identifier
interventional
72
1 country
1
Brief Summary
This study aims to compare the effect of the use of supraglottic jet oxygenation and ventilation (SJOV) with high-flow nasal oxygen therapy (HFNO) on reducing the rate of hypoxia during gastrointestinal endoscopic procedures in deeply sedated patients at high altitudes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2022
CompletedFirst Posted
Study publicly available on registry
July 26, 2022
CompletedStudy Start
First participant enrolled
October 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2023
CompletedOctober 17, 2022
October 1, 2022
5 months
July 22, 2022
October 13, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Hypoxia during sedation
An SPO2 of 75 - 89% for \< 60 s
During sedation procedure
Secondary Outcomes (3)
respiratory-related complications
During sedation procedure
cardiovascular-related complications
During sedation procedure
fatal complications
from sedation initiation to 20 min after patients are awake
Study Arms (2)
Supraglottic jet oxygenation and ventilation
EXPERIMENTALSupraglottic jet oxygenation and ventilation is conducted for the participants during sedation.
High-flow nasal oxygen therapy
ACTIVE COMPARATORHigh-flow nasal oxygen therapy is conducted for the participants during sedation.
Interventions
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. The initial settings of SJOV were as follows: driving pressure (DP) 15 psi; respiratory rate (RR) 20 bpm; inspiratory-to-expiratory (I/E) ratio 1:2, and gas supply, 100% oxygen.
HFNO is conducted. Oxygen supplementation is delivered at 35 liters min-1 with a fraction of inspired oxygen (FiO2) of 100%.
Eligibility Criteria
You may qualify if:
- years or older;
- underwent routine gastrointestinal endoscopy under procedural sedation;
- consented to participate in this trial.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tibet autonomous region people's hospital
Lhasa, Tibet, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yi Feng
Peking University People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chair of Department of Anesthesiology
Study Record Dates
First Submitted
July 22, 2022
First Posted
July 26, 2022
Study Start
October 14, 2022
Primary Completion
February 28, 2023
Study Completion
February 28, 2023
Last Updated
October 17, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share