New airway management for painless gastroenteroscopy

Randomized Controlled Clinical Study of the Incidence of Hypoxia in a Novel Oropharyngeal Airway During Painless Gastroenteroscopy

This study is testing a new way to manage airways during painless gastroenteroscopy to see if it can keep patients, especially those who are obese or elderly, safer and more comfortable.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 228 (estimated)
• Ages: 18 Years to 95 Years
• Sex: All
• Sponsor: Qianfoshan Hospital (Academic / other)
• Locations: 1 site (Jinan)
• Trial ID: NCT06304337 on ClinicalTrials.gov

What this trial studies

This study investigates a new oropharyngeal airway management technique for patients undergoing painless gastroenteroscopy. The focus is on preventing airway obstruction during anesthesia, particularly in obese and elderly patients who are at higher risk for hypoxia. The study will monitor the incidence of hypoxia, cough, laryngeal spasm, and various adverse events, while also assessing endoscopist satisfaction and the required dosage of anesthetics. The goal is to enhance patient safety and comfort during the procedure.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-95 with ASA physical status I or II and Mallampati grades I or II.

Not a fit: Patients with severe respiratory, cardiac, or renal conditions, as well as those with certain infections or bleeding disorders, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of airway obstruction and improve oxygenation during gastroenteroscopy.

How similar studies have performed: While similar airway management techniques have been explored, this specific approach using a new oropharyngeal airway device is relatively novel.

Eligibility criteria

Inclusion Criteria:Voluntary acceptance;Asa1-2 level;Age 18-95y;Mallampati grades Ⅰ or Ⅱ

Exclusion Criteria:

1. Patients with blood clotting disorders or a tendency to oropharyngeal bleeding, mucosal damage or space occupation, difficulty in placing oropharyngeal airway, etc., who cannot perform oropharyngeal airway ventilation;
2. Severe cardiac insufficiency (\<4mets);
3. Patients with severe renal insufficiency (requiring dialysis before surgery);
4. Diagnosed severe liver insufficiency;
5. Diagnosed with chronic obstructive pulmonary disease (COPD) or currently suffering from other acute or chronic lung diseases, requiring long-term or intermittent oxygen therapy;
6. Increased intracranial pressure;
7. Upper respiratory tract infections such as mouth, nose or throat;
8. Fever (core body temperature \>37.5 degrees Celsius);
9. a confirmed diagnosis of pregnancy or breastfeeding;
10. Allergic to sedatives such as propofol or equipment such as tape;
11. Emergency surgery;
12. Multiple trauma;
13. SpO2 \< 95% in preoperative breathing air;

Where this trial is running

Jinan

• The First Affiliated Hospital of Shandong First Medical University（Qianfoshan Hospital, Shandong Province） — Jinan, China (Recruiting)

Study contacts

• Study coordinator: Jianbo Wu

Conditions Airway Management