SJOV vs. HFNO for Hypoxia During Procedural Sedation at High Altitudes

Not Applicable

Recruiting

• Conditions: Hypoxia; High Altitude
• Interventions: Procedure: HFNO; Procedure: SJOV

• Registration Number: NCT05474287
• Lead Sponsor: Peking University People's Hospital

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.

Detailed Description

The participants will be randomly allocated to either SJOV or HFNO in a 1:1 ratio using block randomization with variable block sizes of four or six randomized. In the HFNO group, oxygen supplementation is delivered at 35 liters min-1 with a fraction of inspired oxygen (FiO2) of 100%. 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. 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.

Study Timeline

• Study First Submitted: 2022-07-22
• Study First Submitted QC: 2022-07-22
• Study First Posted: 2022-07-26
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-13
• Study Start: 2022-10-14
• Last Update Posted: 2022-10-17
• Primary Completion: 2023-02-28
• Study Completion: 2023-02-28

Recruitment & Eligibility

• Status: RECRUITING
• 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
High-flow nasal oxygen therapy	HFNO	High-flow nasal oxygen therapy is conducted for the participants during sedation.
Supraglottic jet oxygenation and ventilation	SJOV	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
fatal complications	from sedation initiation to 20 min after patients are awake	severe anaphylactic reactions, myocardial infarction, cardiac arrest and death
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)

Trial Locations

Locations (1)

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