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

Hypoxemia During Deep Sedation for Gastrointestinal Endoscopy at High Altitudes: High-flow Nasal Oxygen Therapy vs. Supraglottic Jet Oxygenation and Ventilation

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.

Study Overview

• Status: Recruiting
• Conditions: Hypoxia; High Altitude
• Intervention / Treatment: Procedure: SJOV; Procedure: HFNO

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bailin Jiang; Phone Number: 86-13810986114; Email: jiangbailin@bjmu.edu.cn
• Study Contact Backup: Name: Ciren Laba; Phone Number: 86-13989098788; Email: lbcr010203@163.com

Study Locations

• China
  • Tibet
    • Lhasa, Tibet, China
      • Recruiting
      • Tibet Autonomous Region People's Hospital
      • Contact: Ciren Laba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supraglottic jet oxygenation and ventilation; Supraglottic jet oxygenation and ventilation is conducted for the participants during sedation.	Procedure: 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.
Active Comparator: High-flow nasal oxygen therapy; High-flow nasal oxygen therapy is conducted for the participants during sedation.	Procedure: HFNO; HFNO is conducted. Oxygen supplementation is delivered at 35 liters min-1 with a fraction of inspired oxygen (FiO2) of 100%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypoxia during sedation	An SPO2 of 75 - 89% for < 60 s	During sedation procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
respiratory-related complications	pulmonary aspiration, respiratory depression (SPO2 = 90-95%) and severe hypoxia (SPO2 < 75% or < 90% for > 60s)	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)	During sedation procedure
fatal complications	severe anaphylactic reactions, myocardial infarction, cardiac arrest and death	from sedation initiation to 20 min after patients are awake

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Collaborators: Tibet Autonomous Region People's Hospital
• Investigators: Principal Investigator: yi feng, Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2022
• Primary Completion (Anticipated): February 28, 2023
• Study Completion (Anticipated): February 28, 2023

Study Registration Dates

• First Submitted: July 22, 2022
• First Submitted That Met QC Criteria: July 22, 2022
• First Posted (Actual): July 26, 2022

Study Record Updates

• Last Update Posted (Actual): October 17, 2022
• Last Update Submitted That Met QC Criteria: October 13, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Altitude Sickness; Hypoxia
• Other Study ID Numbers: XZ2022ZR-ZY11-Z

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No