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

Supraglottic Jet Oxygenation and Ventilation (SJOV) for Hypoxemia During Deep Sedation for Gastrointestinal Endoscopy at High-altitude

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.

Study Overview

• Status: Recruiting
• Conditions: Hypoxia; High Altitude
• Intervention / Treatment: Procedure: Supraglottic jet oxygenation and ventilation; Procedure: Nasal cannula oxygen supply

Detailed 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.

• 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: Laba Ciren; Phone Number: 86-13989098788; Email: lbcr010203@163.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• 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: Supraglottic jet oxygenation and ventilation; 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.
Placebo Comparator: nasal cannula oxygen supply; Oxygen supplementation is delivered via a nasal cannula to the participants during sedation.	Procedure: Nasal cannula oxygen supply; Oxygen supplementation at 2 liters min-1 is delivered via a nasal cannula

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events related to Supraglottic Jet Oxygenation and Ventilation	pharyngalgia, xerostomia, nasal bleeding, and barotrauma	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

Publications and helpful links

General Publications

• Jiang B, Li Y, Ciren D, Dawa O, Feng Y, Laba C. Supraglottic jet oxygenation and ventilation decreased hypoxemia during gastrointestinal endoscopy under deep sedation at high altitudes: a randomized clinical trial. BMC Anesthesiol. 2022 Nov 14;22(1):348. doi: 10.1186/s12871-022-01902-3.

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2022
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: March 22, 2022
• First Submitted That Met QC Criteria: March 30, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 21, 2022
• Last Verified: April 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: SJOVGETBHP

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