High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Sedated Gastrointestinal Endoscopes in Obesity

NCT04500392 | Unknown

• 1 other identifier: HFNOIO
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 3

Brief Summary

Hypoxia is the most common adverse event during gastrointestinal endoscopes sedated with propofol and sufentanil, especially in obese people. In the present study, high-flow nasal cannula oxygenation will be utilized in order to reduce the incidence of hypoxia among obesity.

Conditions

Hypoxia; Gastric Cancer; Esophagus Cancer; Polyp of Colon; Colon Cancer

Keywords

Hypoxia; Gastrointestinal endoscopes; High-flow nasal cannula Oxygenation

Outcome Measures

Primary Outcomes (1)

• The incidence of hypoxia

  (75% ≤ SpO2 \< 90% for \<60 s)

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

Secondary Outcomes (3)

• The incidence of subclinical respiratory depression

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

• The incidence of severe hypoxia

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

• Other adverse events include other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force and HFNC supportive oxygen therapy-related adverse events.

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

Study Arms (2)

Control group

ACTIVE COMPARATOR

Oxygen(up to 6L/min) supplied with a regular nasal catheter

Device: Regular nasal cannula

High-flow nasal cannula group

EXPERIMENTAL

Oxygen(up to 60L/min) supplied with high-flow nasal cannula

Device: High-flow nasal cannula oxygenation

Interventions

High-flow nasal cannula oxygenation DEVICE

Oxygen is supplied with a high-flow nasal cannula oxygenation device#the flow is up to 60L/min

High-flow nasal cannula group

Regular nasal cannula DEVICE

Oxygen is supplied with a regular nasal cannula #the flow is up to 6L/min

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing gastrointestinal endoscopes
• age≥18 years old and ≤70 years old
• patients or family members signed informed consent form
• ASA classification I-II
• BMI≥ 28kg/m²

You may not qualify if:

• Coagulation disorders or a tendency of nose bleeding;
• An episode/exacerbation of congestive heart failure (CHF) that requires a change in medication, diet or hospitalization from any cause in the last 6 months;
• Severe aortic stenosis or mitral stenosis;
• Cardiac surgery involving thoracotomy (e.g., coronary artery bypass graft (CABG), valve replacement surgery) in the last 6 months;
• Acute myocardial infarction in the last 6 months;
• Acute arrhythmia (including any tachycardia - or bradycardia) with the fluid of hemodynamics instability;
• Diagnosed chronic obstructive pulmonary disease or current other acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy);
• Increased intracranial pressure;
• ASA classification Ⅲ-Ⅳ ;
• Mouth, nose, or throat infection;
• Liver and kidney disease
• Fever, defined as core body temperature \> 37.5℃;
• Pregnancy, breastfeeding or positive pregnancy test;
• Emergency procedure;
• Patients or family members refused to participate

Sponsors & Collaborators

• RenJi Hospital: lead
• Shanghai Tongji Hospital, Tongji University School of Medicine: collaborator
• Shanghai Oriental Hospital, Tongji University School of Medicine: collaborator

Study Sites (3)

Shanghai Tongji Hospital

Shanghai, Shanghai, China, 200065, China

RECRUITING

Shanghai Oriental Hospital

Shanghai, Shanghai, China, 200120, China

RECRUITING

Renji hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, Shanghai, China, 200127, China

RECRUITING

Related Publications (1)

• Wang L, Zhang Y, Han D, Wei M, Zhang J, Cheng X, Zhang Y, Shi M, Song Z, Wang X, Zhang X, Su D. Effect of high flow nasal cannula oxygenation on incidence of hypoxia during sedated gastrointestinal endoscopy in patients with obesity: multicentre randomised controlled trial. BMJ. 2025 Feb 11;388:e080795. doi: 10.1136/bmj-2024-080795.

  PMID: 39933757 DERIVED

MeSH Terms

Conditions

Hypoxia; Stomach Neoplasms; Esophageal Neoplasms; Colonic Polyps; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Head and Neck Neoplasms; Esophageal Diseases; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases

Study Officials

• Diansan Su, Dr.

  Renji Hospital, Shanghai Jiaotong University, Shanghai, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diansan Su, Dr.

CONTACT

+862168383702; diansansu@yahoo.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: Vice Chair of the Department of Anesthesiology

Study Record Dates

• First Submitted: August 2, 2020
• First Posted: August 5, 2020
• Study Start: May 6, 2021
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: January 11, 2024

Record last verified: 2024-01

Locations

CN (3)