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

Hypoxia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05304923
• Other study ID #: SJOVGETBHP
• Status: Recruiting
• Phase: N/A
• Start date: April 21, 2022
• Est. completion date: August 2022

Study information

• Verified date: April 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 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: August 2022
• Est. primary completion date: August 2022
• 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:
• Supraglottic jet oxygenation and ventilation
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.
• Nasal cannula oxygen supply
Oxygen supplementation at 2 liters min-1 is delivered via a nasal cannula

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
Other	Adverse events related to Supraglottic Jet Oxygenation and Ventilation	pharyngalgia, xerostomia, nasal bleeding, and barotrauma	20 min after patients are awake
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