Status:
COMPLETED
Nasal Mask Kit in Gastrointestinal Endoscopy
Lead Sponsor:
RenJi Hospital
Collaborating Sponsors:
Henan Provincial People's Hospital
First Affiliated Hospital of Kunming Medical University
Conditions:
Hypoxia
Gastric Cancer
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Hypoxia is the most common adverse event in gastrointestinal endoscopes sedated with propofol. The nasal mask oxygen kit has good sealing to ensure an adequate oxygen supply and is convenient and econ...
Eligibility Criteria
Inclusion
- 18≤ Age ≤60
- patients undergoing combined gastroendoscopy and colonoscopy procedure
- patients signed informed consent form
- ASA classification I-II
- Estimated procedure time \<=45min
Exclusion
- Coagulation disorders or a tendency of nose bleeding
- Diagnosed heart disease (heart failure, angina, myocardial infarction, arrhythmia, etc.)
- Diagnosed chronic obstructive pulmonary disease or current other acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy)
- hypoxia (SpO2\< 90 % )
- Upper respiratory tract infection
- increased intracranial pressure
- Fever (core body temperature \>37.5 ℃)
- Pregnancy, breastfeeding, or positive pregnancy test
- Emergency procedure or surgery
- Multiple trauma
- Allergy to propofol or tape and adhesives
- BMI\<18.5 or BMI\>30
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 6 2023
Estimated Enrollment :
1204 Patients enrolled
Trial Details
Trial ID
NCT05405530
Start Date
September 1 2022
End Date
June 6 2023
Last Update
June 5 2025
Active Locations (3)
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1
Henan Provincial People's Hospital
Zhengzhou, Henan, China, 450003
2
Renji Hospital
Shanghai, Shanghai Municipality, China, 200127
3
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China, 650032