HypoxemiaNCT07791979
High-Flow Nasal Cannula Oxygenation During Sedated Gastrointestinal Endoscopy in Patients With Chronic Obstructive Pulmonary Disease
A study testing High-flow nasal cannula in people with Hypoxemia and Gastric Cancer (Diagnosis), run by Zhejiang University at 1 site in China.
Trial summary
Hypoxemia is the most common adverse event during propofol sedation for gastrointestinal endoscopy in patients with chronic obstructive pulmonary disease (COPD) due to diminished pulmonary reserve. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxemia, Gastric Cancer (Diagnosis), Chronic Obstructive Pulmonary Disease (COPD)
- 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
- 90 participants
- Where
- 1 siteChina
- Study dates
- 29 Aug 2026to 23 Feb 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;
- Confirmed diagnosis of chronic obstructive pulmonary disease (COPD);
- Scheduled for elective sedated gastroenteroscopy (gastroscopy, colonoscopy, or combined gastroscopy and colonoscopy);
- Expected procedure duration ≤45 minutes;
- Provision of written informed consent by the participant.
Who cannot join
- Patients with absolute contraindications to high-flow therapy, including but not limited to confirmed diagnosis of complete upper airway obstruction, basilar skull fracture or nasal bone fracture, pneumothorax, or pneumomediastinum.;
- American Society of Anesthesiologists (ASA) Physical Status class ≥ IV;
- Requirement for planned endotracheal intubation;
- Existing tracheostomy;
- Confirmed pregnancy or currently breastfeeding;
- Known allergy to sedative agents such as propofol;
- Current participation in another interventional clinical trial;
- Any other condition deemed by the investigator to make the patient unsuitable for trial participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Diansan Su, +8618616514088, diansansu@yahoo.com
About this study
Official title: High-Flow Nasal Cannula Oxygenation During Sedated Gastrointestinal Endoscopy in Patients With Chronic Obstructive Pulmonary Disease: A Single-Arm Simon Two-Stage Study
Hypoxemia is the most common adverse event during propofol sedation for gastrointestinal endoscopy in patients with chronic obstructive pulmonary disease (COPD) due to diminished pulmonary reserve. Although high-flow nasal cannula (HFNC) oxygenation has been shown to effectively reduce hypoxemia during sedated endoscopy in obese patients, its application in COPD patients remains an evidence gap, largely owing to the traditional concern that high-concentration oxygen may suppress respiratory drive and exacerbate CO₂ retention. This study aims to investigate whether HFNC can reduce the incidence of hypoxemia during sedated gastrointestinal endoscopy in patients with COPD.
- Conditions
- Hypoxemia, Gastric Cancer (Diagnosis), Chronic Obstructive Pulmonary Disease (COPD), Esophageal Cancer
- Being tested
- High-flow nasal cannula
- Keywords
- high-flow nasal cannula, Hypoxemia, Chronic Obstructive Pulmonary Disease, Sedation, Gastrointestinal Endoscopy
- Medical subject headings
- Hypoxia, Stomach Neoplasms, Disease, Pulmonary Disease, Chronic Obstructive, Esophageal Neoplasms
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 hypoxemia
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 hypoxemia
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 posted28 Aug 2026
- Study start29 Aug 2026 (estimated)
- Primary completion23 Feb 2027 (estimated)
- Study completion23 Feb 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.
- 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
- 90 participants (estimated)
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
- NCT07791979
- Sponsor's protocol ID
- ZJU2026C174
- Status last verified
- Aug 2026
- First submitted
- 23 Aug 2026
- Last updated
- 28 Aug 2026
- 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 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Flow Nasal Cannula Oxygenation During Sedated Gastrointestinal Endoscopy in Patients With Chronic Obstructive Pulmonary Disease: A Single-Arm Simon Two-Stage Study
- ClinicalTrials.gov ID
- NCT07791979
- Acronym / sponsor ID
- ZJU2026C174
- Conditions
- Hypoxemia, Gastric Cancer (Diagnosis), Chronic Obstructive Pulmonary Disease (COPD), Esophageal Cancer
- Keywords
- high-flow nasal cannula, Hypoxemia, Chronic Obstructive Pulmonary Disease, Sedation, Gastrointestinal Endoscopy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 29 Aug 2026 (estimated)
- Primary completion
- 23 Feb 2027 (estimated)
- Study completion
- 23 Feb 2027 (estimated)
- First posted
- 28 Aug 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.
Hypoxemia is the most common adverse event during propofol sedation for gastrointestinal endoscopy in patients with chronic obstructive pulmonary disease (COPD) due to diminished pulmonary reserve. Although high-flow nasal cannula (HFNC) oxygenation has been shown to effectively reduce hypoxemia during sedated endoscopy in obese patients, its application in COPD patients remains an evidence gap, largely owing to the traditional concern that high-concentration oxygen may suppress respiratory drive and exacerbate CO₂ retention. This study aims to investigate whether HFNC can reduce the incidence of hypoxemia during sedated gastrointestinal endoscopy in patients with COPD.
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;
- Confirmed diagnosis of chronic obstructive pulmonary disease (COPD);
- Scheduled for elective sedated gastroenteroscopy (gastroscopy, colonoscopy, or combined gastroscopy and colonoscopy);
- Expected procedure duration ≤45 minutes;
- Provision of written informed consent by the participant.
Key exclusion criteria (8 listed)
- Patients with absolute contraindications to high-flow therapy, including but not limited to confirmed diagnosis of complete upper airway obstruction, basilar skull fracture or nasal bone fracture, pneumothorax, or pneumomediastinum.;
- American Society of Anesthesiologists (ASA) Physical Status class ≥ IV;
- Requirement for planned endotracheal intubation;
- Existing tracheostomy;
- Confirmed pregnancy or currently 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 hypoxemia
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 hypoxemia
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 28 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Hypoxemia
Enrolling by invitation
Extubation Safety Via Microstream EtCO₂ (IPI) Monitoring
Hypoxemia
Not yet recruitingPhase 2
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
Not yet recruiting
HFNC vs Conventional Oxygen During Gastrocolonoscopy in Elderly Patients
Hypoxemia, Eldery People
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.
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 Gastric Cancer (Diagnosis), 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 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 28 Aug 2026. 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?
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 hypoxemia (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 28 Aug 2026.