NCT05304923

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
21 days until next milestone

Study Start

First participant enrolled

April 21, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

April 28, 2022

Status Verified

April 1, 2022

Enrollment Period

3 months

First QC Date

March 22, 2022

Last Update Submit

April 21, 2022

Conditions

HypoxiaHigh Altitude

Outcome Measures

Primary Outcomes (1)

  • Hypoxia during sedation

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

    During sedation procedure

Secondary Outcomes (3)

  • respiratory-related complications

    During sedation procedure

  • cardiovascular-related complications

    During sedation procedure

  • fatal complications

    from sedation initiation to 20 min after patients are awake

Other Outcomes (1)

  • Adverse events related to Supraglottic Jet Oxygenation and Ventilation

    20 min after patients are awake

Study Arms (2)

Supraglottic jet oxygenation and ventilation

EXPERIMENTAL

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

Procedure: Supraglottic jet oxygenation and ventilation

nasal cannula oxygen supply

PLACEBO COMPARATOR

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

Procedure: Nasal cannula oxygen supply

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.

Supraglottic jet oxygenation and ventilation
Nasal cannula oxygen supplyPROCEDURE

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

nasal cannula oxygen supply

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older;
  • underwent routine gastrointestinal endoscopy under procedural sedation;
  • consented to participate in this trial. -

You may not qualify if:

  • 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. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tibet autonomous region people's hospital

Lhasa, Tibet, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 36376852DERIVED

MeSH Terms

Conditions

HypoxiaAltitude Sickness

Interventions

Ventilation

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Environment, ControlledEnvironmentEnvironment and Public Health

Study Officials

  • Yi Feng

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bailin Jiang

CONTACT

86-13810986114jiangbailin@bjmu.edu.cn

Laba Ciren

CONTACT

86-13989098788lbcr010203@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair of Department of Anesthesiology

Study Record Dates

First Submitted

March 22, 2022

First Posted

March 31, 2022

Study Start

April 21, 2022

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

April 28, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)