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RecruitingNCT07252102Updated Jan 20, 2026

Effect of HFNC on Incidence of Hypoxia During Sedated Gastrointestinal Endoscopy in Critical Patients

An interventional study of High-flow nasal catheter oxygen and regular nasal catheter oxygen in Liver Cirrhosis, Polyps of Colon and Gastrointestinal Dysfunction, sponsored by Zhejiang University. Recruiting at 3 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-01-20.

Sponsored by Zhejiang University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Nov 2025; still recruiting 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
450
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Liver Cirrhosis
  • Polyps of Colon
  • Gastrointestinal Dysfunction

Keywords

  • critical patients
  • HFNC
  • High flow nasal cannulas oxyge
  • hypoxia
03

In context

Liver Cirrhosis

1,298 studies on the registry are indexed under Liver Cirrhosis; 338 are open to participants now.

This study's planned enrollment of 450 is above the median of 78 across 739 interventional studies indexed under Liver Cirrhosis.

Browse Liver Cirrhosis studies →

Lead sponsor

Zhejiang University is the lead sponsor of 356 studies on the registry; 166 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 18≤ age ≤80, gender is not limited;
  2. Patients undergoing elective gastroenteroscopy or treatment;
  3. Ⅲ\~Ⅳ;
  4. 18 kg/m2≤≤28kg/m2;
  5. The operation time of gastroenteroscopy is expected to be no more than 60min;
  6. Clearly understand, voluntarily participate in the study, and have from myself or my family members.

Exclusion criteria

Exclusion Criteria:

  1. 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;
  2. acute respiratory infections and asthma attacks;
  3. Patients diagnosed with ;
  4. Clear difficult airway;
  5. Acute upper gastrointestinal bleeding with shock;
  6. Gastrointestinal obstruction with gastric content retention;
  7. Allergic to sedatives such as propofol;
  8. Persons with no capacity for civil conduct such as cognitive dysfunction.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
450 participants (estimated)

Study arms

  • Experimental
    High-flow nasal catheter oxygen

    Device: High-flow nasal catheter oxygen

  • Active comparator
    Regular nasal catheter oxygen

    Device: regular nasal catheter oxygen

Interventions

  • DeviceHigh-flow nasal catheter oxygen

    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.

  • Deviceregular nasal catheter oxygen

    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.

06

What researchers measure

Primary outcomes

  1. Incidence of hypoxia

    75%≤ SpO2 \< 90% and \< 60S

    Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours

Secondary outcomes

  1. Incidence of severe hypoxia

    SpO2\<75% for any duration, or 75%≤SpO2 \< 90%, ≥60s

    Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours

  2. Incidence of subclinical respiratory depression

    90%≤ SpO2\<95%

    Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours

Other outcomes

  1. The incidence of other adverse events

    Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force

    Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours

07

Study locations

3 of 3 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07252102
Responsible party
Diansan Su (Chief, Department of Anesthesiology, the First Affiliated Hospital of Zhejiang University School of Medicine, Zhejiang University) — Principal investigator
First posted
Nov 26, 2025
Start date
Nov 20, 2025
Primary completion
Dec 28, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Jan 20, 2026

Study contacts

Diansan SU, Cheif of Anesthesiology Department, PhD
Contact
184872238@qq.com
+8618616514088
Shuying Fu
Contact
124045832@qq.com
+8613616619870

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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