New mask for sedation during upper gastrointestinal endoscopy
Anesthesia Endoscope Mask is Applied to Sedation Upper Gastrointestinal Endoscopic Diagnosis and Treatment: Multi-center, Prospective, Randomized Control, Open Clinical Research
This study is testing a new mask for delivering anesthesia during upper gastrointestinal endoscopy to see if it is safer and more effective than the usual nasal tube for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1208 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Sichuan Provincial People's Hospital Academic / other |
| Locations | 5 sites (Chengdu, Sichuan and 4 other locations) |
| Trial ID | NCT06085859 on ClinicalTrials.gov |
What this trial studies
This study investigates the efficacy and safety of a new anesthesia endoscope mask compared to traditional nasal tube oxygen delivery in patients undergoing sedation for upper gastrointestinal endoscopy. It is a multicenter, prospective clinical trial that aims to assess whether the new mask can enhance airway safety and effectiveness during examinations. The goal is to improve examination efficiency and reduce failure rates, ultimately providing safety assurance for early diagnosis and treatment of upper gastrointestinal diseases in high-risk populations.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for upper gastrointestinal sedation procedures and have a baseline oxygen saturation of 95% or higher.
Not a fit: Patients with a history of difficulties in mask ventilation or those at risk of aspiration may not benefit from this study.
Why it matters
Potential benefit: If successful, this could enhance patient safety and comfort during gastrointestinal procedures, leading to better diagnostic outcomes.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving patient outcomes with non-invasive ventilation techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years; 2. Upcoming upper gastrointestinal sedation procedure; 3. Classification under the American Association of Anesthesiologists (ASA) status I-III; 4. Baseline oxygen saturation (SpO2) ≥95% in ambient air conditions. Exclusion Criteria: 1. Individuals with previously documented difficulties in mask ventilation (DMV); 2. Patients predisposed to aspiration risks or episodes of vomiting; 3. Facial or jaw injuries or congenital abnormalities that render conventional face mask application infeasible; 4. An inability or unwillingness to utilize the novel disposable anesthesia face mask.
Where this trial is running
Chengdu, Sichuan and 4 other locations
- Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (Recruiting)
- First People's Hospital of Liangshan Yi Autonomous Prefecture — Liangshan, Sichuan, China (Recruiting)
- Second People's Hospital of Yibin — Yibin, Sichuan, China (Recruiting)
- Ziyang People's Hospital — Ziyang, Sichuan, China (Recruiting)
- Chengdu Second People's Hospital — Sichuan, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.