HypoxiaNCT06710613
Efficacy of High-flow Nasal Oxygen in Preventing Hypoxia During Gastrointestinal Endoscopy: a Retrospective Cohort Study
An observational study of Hypoxia, run by Fengli Liu at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypoxia
- How many people
- 900 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2024to 1 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients who underwent painless gastroscopy
Who may be able to join
- Patients aged 18 to 70
- Undergoing painless gastroscopy under intravenous anesthesia
Who cannot join
- Severe respiratory disease
- History of nasal bleeding or mucosal injury
- Emergency cases
- Pregnant or lactating female
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hypoxia
- Keywords
- High flow nasal cannula oxygen
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| control group | conventional nasal cannula oxygen group | |
| experimental group | high flow nasal cannula oxygen group |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of hypoxia
SpO2 levels less than 90%
Measured: 60 seconds
Secondary outcomes (1)
the incidence of subclinical respiratory depression and adverse events
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. )
Measured: 30 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start1 Nov 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fengli Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fengli Liu, Nanchang University
- Investigators
- Fengli Liu, master, Principal investigator, Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06710613
- Sponsor's protocol ID
- LY2024-275-B
- Status last verified
- Dec 2024
- First submitted
- 23 Nov 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of High-flow Nasal Oxygen in Preventing Hypoxia During Gastrointestinal Endoscopy: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06710613
- Acronym / sponsor ID
- LY2024-275-B
- Conditions
- Hypoxia
- Keywords
- High flow nasal cannula oxygen
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Fengli LiuUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 29 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | – | –conventional nasal cannula oxygen group |
| experimental group | – | –high flow nasal cannula oxygen group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients who underwent painless gastroscopy
Key inclusion criteria (2 listed)
- Patients aged 18 to 70
- Undergoing painless gastroscopy under intravenous anesthesia
Key exclusion criteria (4 listed)
- Severe respiratory disease
- History of nasal bleeding or mucosal injury
- Emergency cases
- Pregnant or lactating female
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
incidence of hypoxia
Time frame: 60 seconds
SpO2 levels less than 90%
1 secondary outcome
the incidence of subclinical respiratory depression and adverse events
Time frame: 30 minute
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fengli Liu, master principal investigator
Nanchang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxia, run by Fengli Liu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of hypoxia (time frame: 60 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.