High-flow nasal oxygen therapy for obese patients during gastroscopy

Study on the Safety of High-flow Nasal Oxygen Therapy With Different Flow Rates in Obese Patients Undergoing Sedative Gastroscopy

This study is testing if high-flow nasal oxygen can help obese patients breathe better during a sedative gastroscopy to prevent low oxygen levels.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 864 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Nanjing First Hospital, Nanjing Medical University (Academic / other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06585306 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of high-flow nasal cannula oxygen therapy (HFNC) in obese patients undergoing sedative gastroscopy to prevent hypoxemia. The study aims to provide high-flow oxygen (20-70 L/min) with adjustable concentrations while maintaining airway patency and moisture. By utilizing HFNC, the trial seeks to reduce complications associated with hypoxia during the procedure, which is particularly relevant for obese patients who are at higher risk due to anatomical and physiological factors. The trial will assess the effectiveness of HFNC compared to standard oxygen therapy during gastroscopy.

Who should consider this trial

Good fit: Ideal candidates for this study are obese patients over 18 years old who are scheduled for sedative gastroscopy and meet specific health criteria.

Not a fit: Patients with contraindications for endoscopic procedures or those with severe respiratory or cardiac conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the safety and comfort of obese patients undergoing gastroscopy by reducing the risk of hypoxemia.

How similar studies have performed: While the use of HFNC is gaining traction, this specific application in obese patients undergoing gastroscopy is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. Patients undergoing sedative gastroscopy
2. Aged over 18.
3. ASA classification I-III
4. Interincisal distance \>6.5cm, no micrognathia, limited mouth opening and limited cervical spine movement
5. Compliance with ethics, patient willing to participate in the trial, signed informed consent form

Exclusion Criteria:

1. Contraindications for endoscopic procedures or patients refusing sedation/anesthesia.
2. Patients with allergies to propofol, eggs, soybeans, or milk.
3. Patients with gastrointestinal obstruction and gastric emptying disorders.
4. Patients with acute pharyngitis, tonsillitis, and upper respiratory tract infections.

5: Patients with acute exacerbations of respiratory diseases such as asthma, bronchitis, and COPD. 6. Patients with acute arrhythmias and severe heart disease (congenital, valvular disease). 7. Patients requiring replacement therapy for severe liver or kidney dysfunction.

8\. Patients with severe mental illnesses requiring medication to control symptoms.

9\. Patients with moderate to severe anemia, coagulation disorders, and hematological diseases. 10. Patients with severe nasal congestion caused by nasal cavity lesions. 11. Pregnant and lactating patients.

Where this trial is running

Nanjing, Jiangsu

• Nanjing First Hospital — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Jing Hu

Conditions Hypoxia; Obesity; Gastrostomy; Obese patients; sedative gastroscopy; HFNC