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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Hypoxemia During Deep Sedation for Gastrointestinal Endoscopy at High Altitudes: High-flow Nasal Oxygen Therapy vs. Supraglottic Jet Oxygenation and Ventilation

Conditions
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Hypoxia, High Altitude

Intervention / Treatment
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* Procedure: SJOV
* Procedure: HFNO


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supraglottic jet oxygenation and ventilation<br>Supraglottic jet oxygenation and ventilation is conducted for the participants during sedation. | Procedure: SJOV<br>* 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.<br>|
| Active Comparator: High-flow nasal oxygen therapy<br>High-flow nasal oxygen therapy is conducted for the participants during sedation. | Procedure: HFNO<br>* HFNO is conducted. Oxygen supplementation is delivered at 35 liters min-1 with a fraction of inspired oxygen (FiO2) of 100%.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoxia during sedation | An SPO2 of 75 - 89% for < 60 s | During sedation procedure | 

Secondary Outcome Measures

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