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

Hypoxia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05474287
• Other study ID #: XZ2022ZR-ZY11-Z
• Status: Recruiting
• Phase: N/A
• Start date: October 14, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: October 2022
• Source: Peking University People's Hospital
• Contact: Bailin Jiang
• Phone: 86-13810986114
• Email: jiangbailin[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Altitude Sickness
• High Altitude
• Hypoxia

Intervention

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

Locations

Country	Name	City	State
China	Tibet autonomous region people's hospital	Lhasa	Tibet

Sponsors (2)

Lead Sponsor	Collaborator
Peking University People's Hospital	Tibet Autonomous Region People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypoxia during sedation	An SPO2 of 75 - 89% for < 60 s	During sedation procedure
Secondary	respiratory-related complications	pulmonary aspiration, respiratory depression (SPO2 = 90-95%) and severe hypoxia (SPO2 < 75% or < 90% for > 60s)	During sedation procedure
Secondary	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
Secondary	fatal complications	severe anaphylactic reactions, myocardial infarction, cardiac arrest and death	from sedation initiation to 20 min after patients are awake