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

Shanghai Jiao Tong University

Status: Enrolling

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

Treatments: Device: High-flow nasal cannula oxygenation; Device: Regular nasal cannula

Study type: Interventional

Funder types: Other

Identifiers

NCT04500392

HFNOIO

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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
• Mental disorders and people without civil capacity

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,000 participants in 2 patient groups

Control group

Active Comparator group

Description:

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

Treatment:

Device: Regular nasal cannula

High-flow nasal cannula group

Experimental group

Description:

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

Treatment:

Device: High-flow nasal cannula oxygenation