Status:
UNKNOWN
Anesthesia Endoscope Mask is Applied to Sedation Upper Gastrointestinal Endoscopic Diagnosis and Treatment
Lead Sponsor:
Sichuan Provincial People's Hospital
Collaborating Sponsors:
Anhui Sanhong Medical Device Technology Co., Ltd
Conditions:
Hypoxemia
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
To investigate the efficacy and safety of new-type mask compared with nasal tube oxygen delivery in patients undergoing sedation of upper gastrointestinal endoscopy
Detailed Description
This study aims to utilize a large sample, multicenter, prospective clinical trial using a new mask oxygen supply technology. If the study confirms that the new mask can improve the airway safety and ...
Eligibility Criteria
Inclusion
- Age ≥ 18 years;
- Upcoming upper gastrointestinal sedation procedure;
- Classification under the American Association of Anesthesiologists (ASA) status I-III;
- Baseline oxygen saturation (SpO2) ≥95% in ambient air conditions.
Exclusion
- Individuals with previously documented difficulties in mask ventilation (DMV);
- Patients predisposed to aspiration risks or episodes of vomiting;
- Facial or jaw injuries or congenital abnormalities that render conventional face mask application infeasible;
- An inability or unwillingness to utilize the novel disposable anesthesia face mask.
Key Trial Info
Start Date :
October 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 8 2023
Estimated Enrollment :
1208 Patients enrolled
Trial Details
Trial ID
NCT06085859
Start Date
October 18 2023
End Date
December 8 2023
Last Update
November 18 2023
Active Locations (5)
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1
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
2
First People's Hospital of Liangshan Yi Autonomous Prefecture
Liangshan, Sichuan, China
3
Second People's Hospital of Yibin
Yibin, Sichuan, China
4
Ziyang People's Hospital
Ziyang, Sichuan, China