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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05474287
Other study ID # XZ2022ZR-ZY11-Z
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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