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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Supraglottic Jet Oxygenation and Ventilation (SJOV) for Hypoxemia During Deep Sedation for Gastrointestinal Endoscopy at High-altitude

Conditions
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Hypoxia, High Altitude

Intervention / Treatment
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* Procedure: Supraglottic jet oxygenation and ventilation
* Procedure: Nasal cannula oxygen supply


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: Supraglottic jet oxygenation and ventilation<br>* Supraglottic jet oxygenation and ventilation 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 are: driving pressure (DP) 15psi, respiratory rate (RR) 20 bpm, inspiratory-to-expiratory (I/E) ratio 1:2, and gas supply 100% oxygen.<br>|
| Placebo Comparator: nasal cannula oxygen supply<br>Oxygen supplementation is delivered via a nasal cannula to the participants during sedation. | Procedure: Nasal cannula oxygen supply<br>* Oxygen supplementation at 2 liters min-1 is delivered via a nasal cannula<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 |