Status:
RECRUITING
High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Sedated Gastrointestinal Endoscopes in Obesity
Lead Sponsor:
RenJi Hospital
Collaborating Sponsors:
Shanghai Tongji Hospital, Tongji University School of Medicine
Shanghai Oriental Hospital, Tongji University School of Medicine
Conditions:
Hypoxia
Gastric Cancer
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Hypoxia is the most common adverse event during gastrointestinal endoscopes sedated with propofol and sufentanil, especially in obese people. In the present study, high-flow nasal cannula oxygenation ...
Eligibility Criteria
Inclusion
- patients undergoing gastrointestinal endoscopes
- age≥18 years old and ≤70 years old
- patients or family members signed informed consent form
- ASA classification I-II
- BMI≥ 28kg/m²
Exclusion
- Coagulation disorders or a tendency of nose bleeding;
- An episode/exacerbation of congestive heart failure (CHF) that requires a change in medication, diet or hospitalization from any cause in the last 6 months;
- Severe aortic stenosis or mitral stenosis;
- Cardiac surgery involving thoracotomy (e.g., coronary artery bypass graft (CABG), valve replacement surgery) in the last 6 months;
- Acute myocardial infarction in the last 6 months;
- Acute arrhythmia (including any tachycardia - or bradycardia) with the fluid of hemodynamics instability;
- Diagnosed chronic obstructive pulmonary disease or current other acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy);
- Increased intracranial pressure;
- ASA classification Ⅲ-Ⅳ ;
- Mouth, nose, or throat infection;
- Liver and kidney disease
- Fever, defined as core body temperature \> 37.5℃;
- Pregnancy, breastfeeding or positive pregnancy test;
- Emergency procedure;
- Patients or family members refused to participate
- Mental disorders and people without civil capacity
Key Trial Info
Start Date :
May 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2024
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT04500392
Start Date
May 6 2021
End Date
January 1 2024
Last Update
January 11 2024
Active Locations (3)
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1
Shanghai Tongji Hospital
Shanghai, Shanghai, China, China, 200065
2
Shanghai Oriental Hospital
Shanghai, Shanghai, China, China, 200120
3
Renji hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, Shanghai, China, China, 200127