Liver CirrhosisNCT07252102
Effect of HFNC on Incidence of Hypoxia During Sedated Gastrointestinal Endoscopy in Critical Patients
A study testing High-flow nasal catheter oxygen and regular nasal catheter oxygen in people with Liver Cirrhosis and Polyps of Colon, run by Zhejiang University at 3 sites in China.
Trial summary
High flow nasal cannula oxygenation (HFNC) offers high flow and concentration oxygen delivery, providing excellent non-respiratory oxygenation. As a relatively new oxygen delivery method, it has gained widespread use. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Cirrhosis, Polyps of Colon, Gastrointestinal Dysfunction
- What is being tested?
- High-flow nasal catheter oxygen and regular nasal catheter oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 3 sitesChina
- Study dates
- 20 Nov 2025to 30 Dec 2026
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18≤ age ≤80, gender is not limited;
- Patients undergoing elective gastroenteroscopy or treatment;
- ASA grade Ⅲ~Ⅳ;
- 18 kg/m2≤BMI≤28kg/m2;
- The operation time of gastroenteroscopy is expected to be no more than 60min;
- Clearly understand, voluntarily participate in the study, and have informed consent from myself or my family members.
Who cannot join
- Patients with nasal congestion, nasal bleeding, recent nasal trauma, recent nasal surgery, increased intracranial pressure and skull fracture, etc., who can not perform high-flow nasal catheter oxygen;
- acute respiratory infections and asthma attacks;
- Patients diagnosed with COPD;
- Clear difficult airway;
- Acute upper gastrointestinal bleeding with shock;
- Gastrointestinal obstruction with gastric content retention;
- Allergic to sedatives such as propofol;
- Persons with no capacity for civil conduct such as cognitive dysfunction.
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, 3 recruiting
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Diansan Su, Cheif of Anesthesiology Department, PhD, 86+18616514088, 184872238@qq.com
- Recruiting
Shenzhen Hospital of Southern Medical University
Shenzhen, Guangdong, 518000
Xianrong Jie, B.M., 86+18898618016, jiexianrong@163.com
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
Shenzhen, Guangdong, 518116
Quan Li, +8618017187087, quanligene@126.com
About this study
Official title: Effect of High Flow Nasal Cannula Oxygenation on Incidence of Hypoxia During Sedated Gastrointestinal Endoscopy in Critical Patients: A Multicentre Randomised Controlled Trial
High flow nasal cannula oxygenation (HFNC) offers high flow and concentration oxygen delivery, providing excellent non-respiratory oxygenation. As a relatively new oxygen delivery method, it has gained widespread use. We have demonstrated that high flow nasal cannula oxygenation reduce the incidence of hypoxia during sedated gastrointestinal endoscopy in patients with American Anesthesiologist Rating (ASA rating) grades 1 to 2 and obesity. We hypothesized that HFNC could mitigate the risk of hypoxia in critical patients during sedated gastrointestinal endoscopy. To confirm this, we selected critical patients with ASA grades 3 to 4 who were scheduled for gastrointestinal endoscopy. We observed and compared the incidence of hypoxia (75%≤SpO2 < 90% and < 60S), severe hypoxia (SpO2<75% for any duration or 75%≤SpO2 < 90%, ≥60s), subclinical respiratory depression (90%≤SpO2 < 95%), respiratory-related adverse events, sedation-related adverse events, and complications associated with high flow nasal cannula oxygenation using HFNC or regular nasal cannula during the sedated gastrointestinal endoscopy.
- Being tested
- High-flow nasal catheter oxygen, regular nasal catheter oxygen
- Keywords
- critical patients, HFNC, High flow nasal cannulas oxyge, hypoxia
- Medical subject headings
- Liver Cirrhosis, Colonic Polyps, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-flow nasal catheter oxygenDevice
Before induction of anesthesia, connect the Airvo2 (HFNC high flow device) special nasal cannula to inhale oxygen, and preoxygenate with an oxygen flow rate of 6L /min. After induction of anesthesia, adjust the oxygen flow rate to 60L /min, oxygen concentration 100%, oxygen temperature 37℃ until the end of gastrointestinal endoscopy.
regular nasal catheter oxygenDevice
Before anesthesia induction, a disposable nasal catheter oxygen inhalation device (covered by HFNC nasal catheter and blinded to the patient) was connected to an oxygen source for pre-oxygen inhalation, 6L/min. After induction of anesthesia, oxygen was continued for 6L/min until the end of gastroenteroscopy.
| Study group | Role | What they receive |
|---|---|---|
| High-flow nasal catheter oxygen | Experimental | Not described Receives: Device: High-flow nasal catheter oxygen |
| Regular nasal catheter oxygen | Active comparator | Not described Receives: Device: regular nasal catheter oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypoxia
75%≤ SpO2 < 90% and < 60S
Measured: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Secondary outcomes (2)
Incidence of severe hypoxia
SpO2<75% for any duration, or 75%≤SpO2 < 90%, ≥60s
Measured: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Incidence of subclinical respiratory depression
90%≤ SpO2<95%
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 posted26 Nov 2025
- Study start20 Nov 2025
- Primary completion28 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 450 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
- NCT07252102
- Sponsor's protocol ID
- ZJU2025C036
- Status last verified
- Jan 2026
- First submitted
- 19 Nov 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Flow Nasal Cannula Oxygenation on Incidence of Hypoxia During Sedated Gastrointestinal Endoscopy in Critical Patients: A Multicentre Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07252102
- Acronym / sponsor ID
- ZJU2025C036
- Keywords
- critical patients, HFNC, High flow nasal cannulas oxyge, hypoxia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- 28 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 26 Nov 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.
High flow nasal cannula oxygenation (HFNC) offers high flow and concentration oxygen delivery, providing excellent non-respiratory oxygenation. As a relatively new oxygen delivery method, it has gained widespread use. We have demonstrated that high flow nasal cannula oxygenation reduce the incidence of hypoxia during sedated gastrointestinal endoscopy in patients with American Anesthesiologist Rating (ASA rating) grades 1 to 2 and obesity. We hypothesized that HFNC could mitigate the risk of hypoxia in critical patients during sedated gastrointestinal endoscopy. To confirm this, we selected critical patients with ASA grades 3 to 4 who were scheduled for gastrointestinal endoscopy. We observed and compared the incidence of hypoxia (75%≤SpO2 < 90% and < 60S), severe hypoxia (SpO2<75% for any duration or 75%≤SpO2 < 90%, ≥60s), subclinical respiratory depression (90%≤SpO2 < 95%), respiratory-related adverse events, sedation-related adverse events, and complications associated with high flow nasal cannula oxygenation using HFNC or regular nasal cannula during the sedated gastrointestinal endoscopy.
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 catheter oxygen | Experimental | Device: High-flow nasal catheter oxygen |
| Regular nasal catheter oxygen | Active comparator | Device: regular nasal catheter oxygen |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18≤ age ≤80, gender is not limited;
- Patients undergoing elective gastroenteroscopy or treatment;
- ASA grade Ⅲ~Ⅳ;
- 18 kg/m2≤BMI≤28kg/m2;
- The operation time of gastroenteroscopy is expected to be no more than 60min;
Key exclusion criteria (8 listed)
- Patients with nasal congestion, nasal bleeding, recent nasal trauma, recent nasal surgery, increased intracranial pressure and skull fracture, etc., who can not perform high-flow nasal catheter oxygen;
- acute respiratory infections and asthma attacks;
- Patients diagnosed with COPD;
- Clear difficult airway;
- Acute upper gastrointestinal bleeding with shock;
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 catheter oxygenBefore induction of anesthesia, connect the Airvo2 (HFNC high flow device) special nasal cannula to inhale oxygen, and preoxygenate with an oxygen flow rate of 6L /min. After induction of anesthesia, adjust the oxygen flow rate to 60L /min, oxygen concentration 100%, oxygen temperature 37℃ until the end of gastrointestinal endoscopy. | Device | High-flow nasal catheter oxygen |
| regular nasal catheter oxygenBefore anesthesia induction, a disposable nasal catheter oxygen inhalation device (covered by HFNC nasal catheter and blinded to the patient) was connected to an oxygen source for pre-oxygen inhalation, 6L/min. After induction of anesthesia, oxygen was continued for 6L/min until the end of gastroenteroscopy. | Device | Regular nasal catheter oxygen |
Primary outcome
Incidence of hypoxia
Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
75%≤ SpO2 < 90% and < 60S
2 secondary outcomes
Incidence of severe hypoxia
Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Incidence of subclinical respiratory depression
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 20 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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 catheter oxygen and regular nasal catheter oxygen in people with Liver Cirrhosis and Polyps of Colon, run by Zhejiang University 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 6 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: looking for participants now, as of the sponsor's last update on 20 Jan 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, Cheif of Anesthesiology Department, PhD (+8618616514088, 184872238@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 20 Jan 2026.