Using high-flow nasal cannula oxygen to reduce hypoxia during gastrointestinal endoscopies in obese patients

High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Sedated Gastrointestinal Endoscopes in Obesity: a Randomized Multicenter Clinical Trial

This study tests if using high-flow nasal cannula oxygen can help obese patients breathe better during gastrointestinal endoscopies compared to regular nasal cannula oxygen.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1000 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: RenJi Hospital (Academic / other)
• Locations: 3 sites (Shanghai, Shanghai, China and 2 other locations)
• Trial ID: NCT04500392 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of high-flow nasal cannula oxygenation in reducing hypoxia during gastrointestinal endoscopies in patients with obesity. It focuses on individuals sedated with propofol and sufentanil, who are at a higher risk of experiencing hypoxia. The study compares the outcomes of high-flow nasal cannula oxygenation to regular nasal cannula oxygen in this patient population. The goal is to enhance patient safety and comfort during these procedures.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 70 with a BMI of 28 kg/m² or higher who are scheduled for gastrointestinal endoscopies.

Not a fit: Patients with severe cardiac or pulmonary conditions, or those classified as ASA III, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the incidence of hypoxia in obese patients undergoing gastrointestinal endoscopies.

How similar studies have performed: While the specific approach of high-flow nasal cannula oxygenation in this context may be novel, similar studies have shown promising results in reducing hypoxia in other settings.

Eligibility criteria

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

Where this trial is running

Shanghai, Shanghai, China and 2 other locations

• Shanghai Tongji Hospital — Shanghai, Shanghai, China, China (Recruiting)
• Shanghai Oriental Hospital — Shanghai, Shanghai, China, China (Recruiting)
• Renji hospital, School of Medicine, Shanghai Jiaotong University — Shanghai, Shanghai, China, China (Recruiting)

Study contacts

• Principal investigator: Diansan Su, Dr. — Renji Hospital, Shanghai Jiaotong University, Shanghai, China
• Study coordinator: Diansan Su, Dr.

Conditions Hypoxia; Gastric Cancer; Esophagus Cancer; Polyp of Colon; Colon Cancer; Gastrointestinal endoscopes; High-flow nasal cannula Oxygenation