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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05474287

Enrollment

Registered

2022-07-26

Start date

2022-10-14

Completion date

2023-02-28

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxia, High Altitude

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.

Interventions

PROCEDURESJOV

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.

PROCEDUREHFNO

HFNO is conducted. Oxygen supplementation is delivered at 35 liters min-1 with a fraction of inspired oxygen (FiO2) of 100%.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Hypoxia during sedation	During sedation procedure	An SPO2 of 75 - 89% for \< 60 s

Secondary

Measure	Time frame	Description
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

Countries

China

Contacts

Primary ContactBailin Jiang

jiangbailin@bjmu.edu.cn86-13810986114

Backup ContactCiren Laba

lbcr010203@163.com86-13989098788

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026