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

Effect of High Flow Nasal Cannula Oxygenation on Incidence of Hypoxia During Sedated Gastrointestinal Endoscopy in Critical Patients: A Multicentre Randomised Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07252102
Enrollment
450
Registered
2025-11-26
Start date
2025-11-20
Completion date
2026-12-30
Last updated
2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Dysfunction, Liver Cirrhosis, Polyps of Colon

Keywords

critical patients, HFNC, High flow nasal cannulas oxyge, hypoxia

Brief 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.

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.

Sponsors

Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1. 18≤ age ≤80, gender is not limited; 2. Patients undergoing elective gastroenteroscopy or treatment; 3. ASA grade Ⅲ\~Ⅳ; 4. 18 kg/m2≤BMI≤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 informed consent from myself or my family members.

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 COPD; 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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of hypoxiaPatients will be followed for the duration of hospital stay, an expected average about 2 hours75%≤ SpO2 \< 90% and \< 60S

Secondary

MeasureTime frameDescription
Incidence of severe hypoxiaPatients will be followed for the duration of hospital stay, an expected average about 2 hoursSpO2\<75% for any duration, or 75%≤SpO2 \< 90%, ≥60s
Incidence of subclinical respiratory depressionPatients will be followed for the duration of hospital stay, an expected average about 2 hours90%≤ SpO2\<95%

Countries

China

Contacts

CONTACTDiansan SU, Cheif of Anesthesiology Department, PhD
184872238@qq.com+8618616514088
CONTACTShuying Fu
124045832@qq.com+8613616619870

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026