HypoxemiaNCT07904260
Effect of High-flow Nasal Cannula Oxygenation on the Incidence of Hypoxemia During Painless Gastrointestinal Endoscopy in Patients at High Risk for Obstructive Sleep Apnea Syndrome in High-altitude Regions
A study testing High-flow nasal cannula Group and Regular Nasal Cannula Group in people with Hypoxemia and Gastric Cancer (Diagnosis), run by Diansan Su at 3 sites in China.
Trial summary
Patients living in high-altitude areas naturally have lower blood oxygen levels. Those at high risk for Obstructive Sleep Apnea (OSA) face an even greater risk of low oxygen during painless gastrointestinal endoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxemia, Gastric Cancer (Diagnosis), Esophageal Cancer
- What is being tested?
- High-flow nasal cannula Group and Regular Nasal Cannula Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 3 sitesChina
- Study dates
- 2 Nov 2026to 31 Oct 2027
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Long-term residence in a high-altitude region (continuous residence in a high-altitude region within the past 1 year).
- STOP-Bang score ≥5.
- Scheduled for sedated gastrointestinal endoscopy (gastroscopy, colonoscopy, or combined gastroscopy + colonoscopy).
- Patients have signed the informed consent form.
Who cannot join
- Patients with absolute contraindications to high-flow nasal oxygen therapy, including confirmed complete upper airway obstruction, skull base fracture, nasal bone fracture, pneumothorax, or pneumomediastinum.
- ASA physical status > IV.
- Planned endotracheal intubation.
- Prior tracheostomy.
- Confirmed pregnancy or current breastfeeding.
- Allergy to sedatives such as propofol.
- Current participation in another clinical trial.
- Patients deemed unsuitable for this trial by the investigator.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Diansan Su, +8618616514088, diansansu@yahoo.com
Haiyan County People's Hospital
Sanjiaocheng, Qinghai, 812200
Peng Qiao, +8618909700105, 939511550@qq.com
Qinghai Provincial Traffic Hospital
Xining, Qinghai, 810000
Yunyun Li, +8618697195691, 709498338@qq.com
Zhongchang Wang, +8618997040267, 50367945@qq.com
About this study
Official title: Effect of High-flow Nasal Cannula Oxygenation on the Incidence of Hypoxemia During Painless Gastrointestinal Endoscopy in Patients at High Risk for Obstructive Sleep Apnea Syndrome in High-altitude Regions: a Multicenter Randomized Controlled Trial
Patients living in high-altitude areas naturally have lower blood oxygen levels. Those at high risk for Obstructive Sleep Apnea (OSA) face an even greater risk of low oxygen during painless gastrointestinal endoscopy. This multicenter study will randomly assign these patients to receive either High-Flow Nasal Oxygen (HFNC) or standard oxygen therapy during their procedure, aiming to find out if HFNC can safely and effectively reduce the risk of low oxygen events.
- Conditions
- Hypoxemia, Gastric Cancer (Diagnosis), Esophageal Cancer, High-altitude Illness, Obstructive Sleep Apnea (OSA)
- Being tested
- High-flow nasal cannula Group, Regular Nasal Cannula Group
- Keywords
- Sedation, high-flow nasal cannula, Hypoxemia, Gastrointestinal Endoscopy, High-altitude illness
- Medical subject headings
- Hypoxia, Stomach Neoplasms, Disease, Esophageal 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 cannula GroupDevice
Using High-flow nasal cannula oxygenation
Regular Nasal Cannula GroupDevice
Using regular nasal cannula for oxygenation
| Study group | Role | What they receive |
|---|---|---|
| High-flow nasal cannula Group | Experimental | In this group, patients use the High-flow nasal cannula Receives: Device: High-flow nasal cannula Group |
| Regular Nasal Cannula Group | Active comparator | In this group, patients use the regular nasal cannula for oxygenation. Receives: Device: Regular Nasal Cannula Group |
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 (3)
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
The incidence of other adverse events
Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force
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 posted29 Oct 2026
- Study start2 Nov 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diansan Su
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Diansan Su, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07904260
- Sponsor's protocol ID
- ZJU2026C215
- Status last verified
- Oct 2026
- First submitted
- 24 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High-flow Nasal Cannula Oxygenation on the Incidence of Hypoxemia During Painless Gastrointestinal Endoscopy in Patients at High Risk for Obstructive Sleep Apnea Syndrome in High-altitude Regions: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07904260
- Acronym / sponsor ID
- ZJU2026C215
- Conditions
- Hypoxemia, Gastric Cancer (Diagnosis), Esophageal Cancer, High-altitude Illness, Obstructive Sleep Apnea (OSA)
- Keywords
- Sedation, high-flow nasal cannula, Hypoxemia, Gastrointestinal Endoscopy, High-altitude illness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- Diansan SuUniversity, hospital or other
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 29 Oct 2026 (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.
Patients living in high-altitude areas naturally have lower blood oxygen levels. Those at high risk for Obstructive Sleep Apnea (OSA) face an even greater risk of low oxygen during painless gastrointestinal endoscopy. This multicenter study will randomly assign these patients to receive either High-Flow Nasal Oxygen (HFNC) or standard oxygen therapy during their procedure, aiming to find out if HFNC can safely and effectively reduce the risk of low oxygen events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-flow nasal cannula Group | Experimental | Device: High-flow nasal cannula GroupIn this group, patients use the High-flow nasal cannula |
| Regular Nasal Cannula Group | Active comparator | Device: Regular Nasal Cannula GroupIn this group, patients use the regular nasal cannula for 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.
- Long-term residence in a high-altitude region (continuous residence in a high-altitude region within the past 1 year).
- STOP-Bang score ≥5.
- Scheduled for sedated gastrointestinal endoscopy (gastroscopy, colonoscopy, or combined gastroscopy + colonoscopy).
- Patients have signed the informed consent form.
Key exclusion criteria (8 listed)
- Patients with absolute contraindications to high-flow nasal oxygen therapy, including confirmed complete upper airway obstruction, skull base fracture, nasal bone fracture, pneumothorax, or pneumomediastinum.
- ASA physical status > IV.
- Planned endotracheal intubation.
- Prior tracheostomy.
- 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 cannula GroupUsing High-flow nasal cannula oxygenation | Device | High-flow nasal cannula Group |
| Regular Nasal Cannula GroupUsing regular nasal cannula for oxygenation | Device | Regular Nasal Cannula Group |
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
3 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
The incidence of other adverse events
Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
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 29 Oct 2026.
Related trials for Hypoxemia
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Extubation Safety Via Microstream EtCO₂ (IPI) Monitoring
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
RecruitingObservational study
Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study
Respiratory Failure, Hypoxemia
Not yet recruitingObservational study
The Role of Ultrasonographic Tracheal Measurements in Predicting Hypoxemia During Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration
ENDOBRONCHIAL ULTRASOUND - TRANSBRONCHIAL NEEDLE ASPIRATION, Hypoxemia
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HFNC vs Conventional Oxygen During Gastrocolonoscopy in Elderly Patients
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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.
3 sites 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 Group and Regular Nasal Cannula Group in people with Hypoxemia and Gastric Cancer (Diagnosis), run by Diansan Su at 3 sites 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 8 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: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Contact Diansan Su (+8618616514088, diansansu@yahoo.com), or a site near the patient. 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 29 Oct 2026.