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

Peking University

Status: Unknown

Conditions: Hypoxia; High Altitude

Treatments: Procedure: Supraglottic jet oxygenation and ventilation; Procedure: Nasal cannula oxygen supply

Study type: Interventional

Funder types: Other

Identifiers

NCT05304923

SJOVGETBHP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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. -

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 2 patient groups, including a placebo group

Supraglottic jet oxygenation and ventilation

Experimental group

Description:

Supraglottic jet oxygenation and ventilation is conducted for the participants during sedation.

Treatment:

Procedure: Supraglottic jet oxygenation and ventilation

nasal cannula oxygen supply

Placebo Comparator group

Description:

Oxygen supplementation is delivered via a nasal cannula to the participants during sedation.

Treatment:

Procedure: Nasal cannula oxygen supply