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

Not Applicable

Recruiting

• Conditions: Polyp of Colon; Hypoxia; Gastric Cancer; Esophagus Cancer; Colon Cancer
• Interventions: Device: High-flow nasal cannula oxygenation; Device: Regular nasal cannula

• Registration Number: NCT04500392
• Lead Sponsor: RenJi Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-02
• Study First Submitted QC: 2020-08-02
• Study First Posted: 2020-08-05
• Study Start: 2021-05-06
• Status Verified: 2024-01
• Primary Completion: 2024-01
• Study Completion: 2024-01
• Last Update Submitted: 2024-01-09
• Last Update Posted: 2024-01-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-flow nasal cannula group	High-flow nasal cannula oxygenation	Oxygen(up to 60L/min) supplied with high-flow nasal cannula
Control group	Regular nasal cannula	Oxygen(up to 6L/min) supplied with a regular nasal catheter

Primary Outcome Measures

Name	Time	Method
The incidence of hypoxia	Patients will be followed for the duration of hospital stay, an expected average of 2 hours]	(75% ≤ SpO2 \< 90% for \<60 s)

Secondary Outcome Measures

Name	Time	Method
The incidence of severe hypoxia	Patients will be followed for the duration of hospital stay, an expected average of 2 hours	(SpO2 \< 75% for any duration or 75% \< SpO2 \< 90% for \>/=60 s)
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
The incidence of subclinical respiratory depression	Patients will be followed for the duration of hospital stay, an expected average of 2 hours	(90% ≤ SpO2 \< 95%)

Trial Locations

Locations (3)

Shanghai Oriental Hospital; 🇨🇳 Shanghai, Shanghai, China, China

Shanghai Tongji Hospital; 🇨🇳 Shanghai, Shanghai, China, China

Renji hospital, School of Medicine, Shanghai Jiaotong University; 🇨🇳 Shanghai, Shanghai, China, China