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

Primary Purpose

Hypoxia, High Altitude

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Supraglottic jet oxygenation and ventilation
Nasal cannula oxygen supply
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypoxia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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. -

Sites / Locations

  • Tibet autonomous region people's hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Supraglottic jet oxygenation and ventilation

nasal cannula oxygen supply

Arm Description

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

Oxygen supplementation is delivered via a nasal cannula to the participants during sedation.

Outcomes

Primary Outcome Measures

Hypoxia during sedation
An SPO2 of 75 - 89% for < 60 s

Secondary Outcome Measures

respiratory-related complications
pulmonary aspiration, respiratory depression (SPO2 = 90-95%) and severe hypoxia (SPO2 < 75% or < 90% for > 60s)
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)
fatal complications
severe anaphylactic reactions, myocardial infarction, cardiac arrest and death

Full Information

First Posted
March 22, 2022
Last Updated
April 21, 2022
Sponsor
Peking University People's Hospital
Collaborators
Tibet Autonomous Region People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05304923
Brief Title
Supraglottic Jet Oxygenation and Ventilation for Gastrointestinal Endoscopy at High-altitude
Official Title
Supraglottic Jet Oxygenation and Ventilation (SJOV) for Hypoxemia During Deep Sedation for Gastrointestinal Endoscopy at High-altitude
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 21, 2022 (Actual)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital
Collaborators
Tibet Autonomous Region People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia, High Altitude

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Supraglottic jet oxygenation and ventilation
Arm Type
Experimental
Arm Description
Supraglottic jet oxygenation and ventilation is conducted for the participants during sedation.
Arm Title
nasal cannula oxygen supply
Arm Type
Placebo Comparator
Arm Description
Oxygen supplementation is delivered via a nasal cannula to the participants during sedation.
Intervention Type
Procedure
Intervention Name(s)
Supraglottic jet oxygenation and ventilation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Nasal cannula oxygen supply
Intervention Description
Oxygen supplementation at 2 liters min-1 is delivered via a nasal cannula
Primary Outcome Measure Information:
Title
Hypoxia during sedation
Description
An SPO2 of 75 - 89% for < 60 s
Time Frame
During sedation procedure
Secondary Outcome Measure Information:
Title
respiratory-related complications
Description
pulmonary aspiration, respiratory depression (SPO2 = 90-95%) and severe hypoxia (SPO2 < 75% or < 90% for > 60s)
Time Frame
During sedation procedure
Title
cardiovascular-related complications
Description
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
Title
fatal complications
Description
severe anaphylactic reactions, myocardial infarction, cardiac arrest and death
Time Frame
from sedation initiation to 20 min after patients are awake
Other Pre-specified Outcome Measures:
Title
Adverse events related to Supraglottic Jet Oxygenation and Ventilation
Description
pharyngalgia, xerostomia, nasal bleeding, and barotrauma
Time Frame
20 min after patients are awake

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18 years or older; underwent routine gastrointestinal endoscopy under procedural sedation; consented to participate in this trial. - Exclusion Criteria: infection of the upper airway; anatomical abnormalities of the face, nose, and upper airway; coagulopathies; anticipated or known difficult airway; known allergy against propofol, soybeans, and egg; absence from the high-altitude environment during the past 3 months. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bailin Jiang
Phone
86-13810986114
Email
jiangbailin@bjmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Laba Ciren
Phone
86-13989098788
Email
lbcr010203@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi Feng
Organizational Affiliation
Peking University People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tibet autonomous region people's hospital
City
Lhasa
State/Province
Tibet
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laba Ciren

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36376852
Citation
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.
Results Reference
derived

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

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