Supraglottic Jet Oxygenation and Ventilation for Gastrointestinal Endoscopy at High-altitude

Not Applicable

• Conditions: High Altitude; Hypoxia
• Interventions: Procedure: Nasal cannula oxygen supply; Procedure: Supraglottic jet oxygenation and ventilation

• Registration Number: NCT05304923
• Lead Sponsor: Peking University People's Hospital

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 Timeline

• Study First Submitted: 2022-03-22
• Study First Submitted QC: 2022-03-30
• Study First Posted: 2022-03-31
• Status Verified: 2022-04
• Study Start: 2022-04-21
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-28
• Primary Completion: 2022-08
• Study Completion: 2022-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

1. 18 years or older;
2. underwent routine gastrointestinal endoscopy under procedural sedation;
3. consented to participate in this trial. -

Exclusion Criteria

1. infection of the upper airway;
2. anatomical abnormalities of the face, nose, and upper airway;
3. coagulopathies;
4. anticipated or known difficult airway;
5. known allergy against propofol, soybeans, and egg;
6. absence from the high-altitude environment during the past 3 months. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nasal cannula oxygen supply	Nasal cannula oxygen supply	Oxygen supplementation is delivered via a nasal cannula to the participants during sedation.
Supraglottic jet oxygenation and ventilation	Supraglottic jet oxygenation and ventilation	Supraglottic jet oxygenation and ventilation is conducted for the participants during sedation.

Primary Outcome Measures

Name	Time	Method
Hypoxia during sedation	During sedation procedure	An SPO2 of 75 - 89% for \< 60 s

Secondary Outcome Measures

Name	Time	Method
respiratory-related complications	During sedation procedure	pulmonary aspiration, respiratory depression (SPO2 = 90-95%) and severe hypoxia (SPO2 \< 75% or \< 90% for \> 60s)
cardiovascular-related complications	During sedation procedure	hypotension (systolic blood pressure \< 90 mmHg), hypertension (systolic blood pressure \> 160 mmHg), bradycardia (heart rate \< 50 beats/min), tachycardia (heart rate \> 120 beats/min)
fatal complications	from sedation initiation to 20 min after patients are awake	severe anaphylactic reactions, myocardial infarction, cardiac arrest and death

Trial Locations

Locations (1)

Tibet autonomous region people's hospital; 🇨🇳 Lhasa, Tibet, China