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

Peking University People's Hospital72 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Hypoxia High Altitude

Interventions

Supraglottic jet oxygenation and ventilationPROCEDURE

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 supplyPROCEDURE

Oxygen supplementation at 2 liters min-1 is delivered via a nasal cannula

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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. -

Locations (1)

Tibet autonomous region people's hospital

Lhasa, Tibet, China

RECRUITING

Outcomes

Primary Outcomes

Hypoxia during sedation

An SPO2 of 75 - 89% for \< 60 s

Time frame: During sedation procedure

Secondary Outcomes

respiratory-related complications

pulmonary aspiration, respiratory depression (SPO2 = 90-95%) and severe hypoxia (SPO2 \< 75% or \< 90% for \> 60s)

Time frame: During sedation procedure

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)

Time frame: During sedation procedure

fatal complications

severe anaphylactic reactions, myocardial infarction, cardiac arrest and death

Time frame: from sedation initiation to 20 min after patients are awake

Central Contacts

Bailin Jiang

CONTACT

86-13810986114 jiangbailin@bjmu.edu.cn

Laba Ciren

CONTACT

86-13989098788 lbcr010203@163.com

Data from ClinicalTrials.gov

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