NCT05510388UnknownNot Applicable
High-flow Nasal Cannula Oxygenation Reduces the Incidence of Hypoxia During Gastroscopy or Colonoscopy Sedated With Propofol in High-risk Patients: a Multi Central Randomized Controlled Study
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- RenJi Hospital
- Enrollment
- 450
- Locations
- 2
- Primary Endpoint
- The incidence of hypoxia
Study Overview
Brief Summary
The objective of this study is to observe the preventive effects of high flow nasal oxygenation on the incidence of hypoxia during gastroscopy or colonoscopy sedated with propofol in high-risk patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ranging from 18 to 80, both sexes
- •Patients receiving selective gastroscopy or colonoscopy or gastroscopy and colonoscopy procedure
- •18 kg/m2<BMI<28kg/m2
- •The anticipated operation time of the procedure shall be less than 30min.
- •Patients should clearly understand and voluntarily participate in the study, with signed informed consent.
Exclusion Criteria
- •Patients with nasal congestion, epistaxis, recent nasal trauma, recent nasal surgery, increased intracranial pressure and skull fracture, etc. who can not tolerate high-flow nasal cannula.
- •Patients diagnosed POCD
- •Patients clearly identified difficult airway
- •Patients with mechanical ventilation
- •Patients with acute respiratory infection and asthma
- •Patients with acute upper gastrointestinal hemorrhage accompanied by shock, severe anemia, gastrointestinal obstruction accompanied by retention of gastric contents
- •Patients with aortic stenosis and carotid stenosis
- •Patients allergic to sedatives such as propofol
- •Patients without civil capacity such as cognitive dysfunction
Outcomes
Primary Outcomes
The incidence of hypoxia
Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Hypoxia refers to 75%≤SpO2\<90%,\<60S
Secondary Outcomes
- Complications related to high-flow nasal cannula(Patients will be followed for the duration of hospital stay, an expected average of 2 hours)
- The incidence of subclinical respiratory depression(Patients will be followed for the duration of hospital stay, an expected average of 2 hours)
- Other adverse events evaluated by the tool of World SIVA(Patients will be followed for the duration of hospital stay, an expected average of 2 hours)
- The incidence of severe hypoxia(Patients will be followed for the duration of hospital stay, an expected average of 2 hours)
Investigators
Study Sites (2)
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