HypoxemiaNCT07155330
High-flow Nasal Cannula Oxygenation in Sedated Endoscopy for High-risk Obstructive Sleep Apnea Patients
A study testing High-flow nasal cannula in people with Hypoxemia and Esophageal Cancer, run by Zhejiang University at 1 site in China.
Trial summary
Hypoxia is the most common adverse event during propofol sedation for gastrointestinal endoscopy. The STOP-BANG questionnaire is a widely used, simple assessment tool for screening obstructive sleep apnea (OSA) risk. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxemia, Esophageal Cancer, Gastric Cancer (Diagnosis)
- What is being tested?
- High-flow nasal cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 5 Sep 2025to 11 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- STOP-Bang score ≥5.
- Scheduled for sedated gastrointestinal endoscopy (gastroscopy, colonoscopy, or combined gastroscopy + colonoscopy).
- The estimated duration of the procedure does not exceed 45 minutes.
- Patients have signed the informed consent form.
Who cannot join
- Coagulation disorders or bleeding tendency (e.g., oral/nasal bleeding risk, mucosal injury, space-occupying obstructions).
- Active upper respiratory tract infection (oral, nasal, or pharyngeal), or fever (core temperature >37.5°C).
- Chronic obstructive pulmonary disease or other acute/chronic pulmonary diseases requiring long-term or intermittent oxygen therapy, or preoperative SpO₂ ≤ 92% on room air.
- Severe organ dysfunction, including: Cardiac insufficiency (<4 METs), Severe renal insufficiency (requiring dialysis), Diagnosed severe hepatic insufficiency, Increased intracranial pressure, ASA physical status ≥ IV.
- Confirmed pregnancy or current breastfeeding.
- Known allergy to sedatives (e.g., propofol) or medical adhesives.
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- Multiple traumatic injuries.
- Current participation in another clinical trial.
- Other conditions deemed unsuitable by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
About this study
Hypoxia is the most common adverse event during propofol sedation for gastrointestinal endoscopy. The STOP-BANG questionnaire is a widely used, simple assessment tool for screening obstructive sleep apnea (OSA) risk. A STOP-Bang score ≥5 indicates high-risk OSA patients who are more prone to hypoxia during sedated endoscopy. Our team's preliminary clinical research found that High-Flow Nasal Cannula (HFNC) may reduce hypoxemia risk, but there are limited dedicated studies focusing specifically on high-risk OSA patients, with controversial results. This study aims to investigate whether HFNC can reduce the incidence of hypoxia during sedated gastrointestinal endoscopy in high-risk obstructive sleep apnea patients.
- Conditions
- Hypoxemia, Esophageal Cancer, Gastric Cancer (Diagnosis), Colon Cancer
- Being tested
- High-flow nasal cannula
- Keywords
- High-Flow Nasal Oxygen, Hypoxemia, Gastrointestinal Endoscopy, Sedation, obstructive sleep apnea
- Medical subject headings
- Hypoxia, Esophageal Neoplasms, Stomach Neoplasms, Disease, Colonic Neoplasms, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-flow nasal cannulaDevice
Using high-flow nasal cannula oxygenation
| Study group | Role | What they receive |
|---|---|---|
| High-flow nasal cannula | Experimental | Using high-flow nasal cannula oxygenation Receives: Device: High-flow nasal cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of hypoxia
75% ≤ SpO2 < 90% for <60 s
Measured: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Secondary outcomes (2)
The incidence of sub-clinical respiratory depression
90% ≤ SpO2 < 95%
Measured: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
The incidence of severe hypoxia
SpO2 < 75% or 75% ≤ SpO2 < 90% for ≥60 s
Measured: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start5 Sep 2025
- Primary completion11 Nov 2025
- Study completion11 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxemiaStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diansan Su, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07155330
- Sponsor's protocol ID
- ZJU2025C128
- Status last verified
- Sep 2025
- First submitted
- 26 Aug 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-flow Nasal Cannula Oxygenation in Sedated Endoscopy for High-risk Obstructive Sleep Apnea Patients
- ClinicalTrials.gov ID
- NCT07155330
- Acronym / sponsor ID
- ZJU2025C128
- Conditions
- Hypoxemia, Esophageal Cancer, Gastric Cancer (Diagnosis), Colon Cancer
- Keywords
- High-Flow Nasal Oxygen, Hypoxemia, Gastrointestinal Endoscopy, Sedation, obstructive sleep apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 5 Sep 2025 (actual)
- Primary completion
- 11 Nov 2025 (actual)
- Study completion
- 11 Nov 2025 (actual)
- First posted
- 4 Sep 2025 (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.
Hypoxia is the most common adverse event during propofol sedation for gastrointestinal endoscopy. The STOP-BANG questionnaire is a widely used, simple assessment tool for screening obstructive sleep apnea (OSA) risk. A STOP-Bang score ≥5 indicates high-risk OSA patients who are more prone to hypoxia during sedated endoscopy. Our team's preliminary clinical research found that High-Flow Nasal Cannula (HFNC) may reduce hypoxemia risk, but there are limited dedicated studies focusing specifically on high-risk OSA patients, with controversial results. This study aims to investigate whether HFNC can reduce the incidence of hypoxia during sedated gastrointestinal endoscopy in high-risk obstructive sleep apnea patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-flow nasal cannula | Experimental | Device: High-flow nasal cannulaUsing high-flow nasal cannula oxygenation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years.
- STOP-Bang score ≥5.
- Scheduled for sedated gastrointestinal endoscopy (gastroscopy, colonoscopy, or combined gastroscopy + colonoscopy).
- The estimated duration of the procedure does not exceed 45 minutes.
- Patients have signed the informed consent form.
Key exclusion criteria (9 listed)
- Coagulation disorders or bleeding tendency (e.g., oral/nasal bleeding risk, mucosal injury, space-occupying obstructions).
- Active upper respiratory tract infection (oral, nasal, or pharyngeal), or fever (core temperature >37.5°C).
- Chronic obstructive pulmonary disease or other acute/chronic pulmonary diseases requiring long-term or intermittent oxygen therapy, or preoperative SpO₂ ≤ 92% on room air.
- Severe organ dysfunction, including: Cardiac insufficiency (<4 METs), Severe renal insufficiency (requiring dialysis), Diagnosed severe hepatic insufficiency, Increased intracranial pressure, ASA physical status ≥ IV.
- Confirmed pregnancy or current breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-flow nasal cannulaUsing high-flow nasal cannula oxygenation | Device | High-flow nasal cannula |
Primary outcome
The incidence of hypoxia
Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
75% ≤ SpO2 < 90% for <60 s
2 secondary outcomes
The incidence of sub-clinical respiratory depression
Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
The incidence of severe hypoxia
Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-flow nasal cannula in people with Hypoxemia and Esophageal Cancer, run by Zhejiang University 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 5 inclusion and 9 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: finished, as of the sponsor's last update on 25 Nov 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The incidence of hypoxia (time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours). 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 25 Nov 2025.