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

NCT07252102 | Recruiting

• 1 other identifier: ZJU2025C036
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 3

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.

Conditions

Polyps of Colon; Gastrointestinal Dysfunction; Liver Cirrhosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence of hypoxia

  75%≤ SpO2 \< 90% and \< 60S

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

Secondary Outcomes (2)

• Incidence of severe hypoxia

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

• Incidence of subclinical respiratory depression

  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

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

Study Arms (2)

High-flow nasal catheter oxygen

EXPERIMENTAL

Device: High-flow nasal catheter oxygen

Regular nasal catheter oxygen

ACTIVE COMPARATOR

Device: regular nasal catheter oxygen

Interventions

regular nasal catheter oxygen 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.

Regular nasal catheter oxygen

High-flow nasal catheter oxygen 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.

High-flow nasal catheter oxygen

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤ age ≤80, gender is not limited;
• Patients undergoing elective gastroenteroscopy or treatment;
• ASA grade Ⅲ\~Ⅳ;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (3)

Shenzhen Hospital of Southern Medical University

Shenzhen, Guangdong, 518000, China

RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center

Shenzhen, Guangdong, 518116, China

RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis; Colonic Polyps; Hypoxia

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Signs and Symptoms, Respiratory; Signs and Symptoms

Central Study Contacts

Diansan SU, Cheif of Anesthesiology Department, PhD

CONTACT

+8618616514088; 184872238@qq.com

Shuying Fu

CONTACT

+8613616619870; 124045832@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Department of Anesthesiology, the First Affiliated Hospital of Zhejiang University School of Medicine

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 26, 2025
• Study Start: November 20, 2025
• Primary Completion (Estimated): December 28, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

CN (3)