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

NCT ID: NCT07252102

Last Updated: 2026-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-20

Study Completion Date

2026-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Cirrhosis Polyps of Colon Gastrointestinal Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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High-flow nasal catheter oxygen

Group Type EXPERIMENTAL

High-flow nasal catheter oxygen

Intervention Type DEVICE

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 oxygen

Group Type ACTIVE_COMPARATOR

regular nasal catheter oxygen

Intervention Type DEVICE

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.

Interventions

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High-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.

Intervention Type DEVICE

regular 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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Diansan Su

Chief, Department of Anesthesiology, the First Affiliated Hospital of Zhejiang University School of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shenzhen Hospital of Southern Medical University

Shenzhen, Guangdong, China

Site Status RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center

Shenzhen, Guangdong, China

Site Status RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Diansan SU, Cheif of Anesthesiology Department, PhD

Role: CONTACT

+8618616514088

Shuying Fu

Role: CONTACT

+8613616619870

Facility Contacts

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Xianrong Jie, B.M.

Role: primary

86+18898618016

Quan Li

Role: primary

+8618017187087

Diansan Su, Cheif of Anesthesiology Department, PhD

Role: primary

86+18616514088

Other Identifiers

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ZJU2025C036

Identifier Type: -

Identifier Source: org_study_id

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