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

NCT ID: NCT05474287

Last Updated: 2022-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-14

Study Completion Date

2023-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypoxia High Altitude

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Supraglottic jet oxygenation and ventilation

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

Group Type EXPERIMENTAL

SJOV

Intervention Type PROCEDURE

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.

High-flow nasal oxygen therapy

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

Group Type ACTIVE_COMPARATOR

HFNO

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

HFNO

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tibet Autonomous Region People's Hospital

OTHER

Sponsor Role collaborator

Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yi Feng, MD

Chair of Department of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yi Feng

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

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Tibet autonomous region people's hospital

Lhasa, Tibet, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Bailin Jiang

Role: CONTACT

86-13810986114

Ciren Laba

Role: CONTACT

86-13989098788

Facility Contacts

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Ciren Laba

Role: primary

Other Identifiers

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XZ2022ZR-ZY11-Z

Identifier Type: -

Identifier Source: org_study_id

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