- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06710613
Efficacy of High-flow Nasal Oxygen in Preventing Hypoxia During Gastrointestinal Endoscopy: a Retrospective Cohort Study
December 11, 2024 updated by: Fengli Liu
During painless gastroscopy, the occurrence of hypoxia is a critical concern, especially under intravenous anesthesia using propofol.
This study aimed to investigate the incidence of hypoxia during painless gastroscopy and evaluate preventive measures.
Study Overview
Status
Active, not recruiting
Conditions
Detailed Description
From June 15 th 2023 to August 15th 2023, 900 patients who underwent elective gastroscopy in the Renji Hospital, Shanghai Jiao Tong University School of Medicine were selected.
They were divided into the high flow nasal cannula oxygen group and the conventional nasal cannula oxygen group by oxygen inhalation.
Patient demographics, Mallampati class, and other relevant factors were compared between the two groups.
Primary outcomes included the incidence hypoxia (SpO2 < 90%), while secondary outcomes included subclinical respiratory depression, and adverse events related to nasal oxygen cannula.
Study Type
Observational
Enrollment (Estimated)
900
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangxi
-
Nanchang, Jiangxi, China, 330000
- Nanchang University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
The patients who underwent painless gastroscopy
Description
Inclusion Criteria:
- Patients aged 18 to 70
- Undergoing painless gastroscopy under intravenous anesthesia
Exclusion Criteria:
- Severe respiratory disease
- History of nasal bleeding or mucosal injury
- Emergency cases
- Pregnant or lactating female
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
control group
conventional nasal cannula oxygen group
|
|
experimental group
high flow nasal cannula oxygen group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
incidence of hypoxia
Time Frame: 60 seconds
|
SpO2 levels less than 90%
|
60 seconds
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the incidence of subclinical respiratory depression and adverse events
Time Frame: 30 minute
|
the incidence of and subclinical respiratory depression (SpO2 levels between 90% and less than 95%) and adverse events(mouth or nasal dryness, headache, nasal mucosal injury with bleeding, barotrauma. )
|
30 minute
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Fengli Liu, master, Nanchang University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2024
Primary Completion (Estimated)
June 1, 2025
Study Completion (Estimated)
June 1, 2025
Study Registration Dates
First Submitted
November 23, 2024
First Submitted That Met QC Criteria
November 26, 2024
First Posted (Actual)
November 29, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 11, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LY2024-275-B
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
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.