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

Peking University

Status: Enrolling

Conditions: Hypoxia; High Altitude

Treatments: Procedure: SJOV; Procedure: HFNO

Study type: Interventional

Funder types: Other

Identifiers

NCT05474287

XZ2022ZR-ZY11-Z

Details and patient eligibility

About

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.

Full 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.

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

Supraglottic jet oxygenation and ventilation

Experimental group

Description:

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

Treatment:

Procedure: SJOV

High-flow nasal oxygen therapy

Active Comparator group

Description:

High-flow nasal oxygen therapy is conducted for the participants during sedation.

Treatment:

Procedure: HFNO