Effect of High Flow Nasal Cannula Oxygenation on Incidence of Hypoxia During Sedated Gastrointestinal Endoscopy in Critical Patients : A Multicentre Randomised Controlled Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 450
- Locations
- 2
- Primary Endpoint
- Incidence of hypoxia
Study Overview
Brief Summary
High flow nasal cannula oxygenation (HFNC) offers high flow and concentration oxygen delivery, providing excellent non-respiratory oxygenation. As a relatively new oxygen delivery method, it has gained widespread use. We have demonstrated that high flow nasal cannula oxygenation reduce the incidence of hypoxia during sedated gastrointestinal endoscopy in patients with American Anesthesiologist Rating (ASA rating) grades 1 to 2 and obesity. We hypothesized that HFNC could mitigate the risk of hypoxia in critical patients during sedated gastrointestinal endoscopy. To confirm this, we selected critical patients with ASA grades 3 to 4 who were scheduled for gastrointestinal endoscopy. We observed and compared the incidence of hypoxia (75%≤SpO2 < 90% and < 60S), severe hypoxia (SpO2<75% for any duration or 75%≤SpO2 < 90%, ≥60s), subclinical respiratory depression (90%≤SpO2 < 95%), respiratory-related adverse events, sedation-related adverse events, and complications associated with high flow nasal cannula oxygenation using HFNC or regular nasal cannula during the sedated gastrointestinal endoscopy.
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
- •18≤ age ≤80, gender is not limited;
- •Patients undergoing elective gastroenteroscopy or treatment;
- •ASA grade Ⅲ~Ⅳ;
- •18 kg/m2≤BMI≤28kg/m2;
- •The operation time of gastroenteroscopy is expected to be no more than 60min;
- •Clearly understand, voluntarily participate in the study, and have informed consent from myself or my family members.
Exclusion Criteria
- •Patients with nasal congestion, nasal bleeding, recent nasal trauma, recent nasal surgery, increased intracranial pressure and skull fracture, etc., who can not perform high-flow nasal catheter oxygen;
- •acute respiratory infections and asthma attacks;
- •Patients diagnosed with COPD;
- •Clear difficult airway;
- •Acute upper gastrointestinal bleeding with shock;
- •Gastrointestinal obstruction with gastric content retention;
- •Allergic to sedatives such as propofol;
- •Persons with no capacity for civil conduct such as cognitive dysfunction.
Arms & Interventions
High-flow nasal catheter oxygen
Intervention: High-flow nasal catheter oxygen (Device)
Regular nasal catheter oxygen
Intervention: regular nasal catheter oxygen (Device)
Outcomes
Primary Outcomes
Incidence of hypoxia
Time Frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
75%≤ SpO2 \< 90% and \< 60S
Secondary Outcomes
- Incidence of severe hypoxia(Patients will be followed for the duration of hospital stay, an expected average about 2 hours)
- Incidence of subclinical respiratory depression(Patients will be followed for the duration of hospital stay, an expected average about 2 hours)
Investigators
Diansan Su
Chief, Department of Anesthesiology, the First Affiliated Hospital of Zhejiang University School of Medicine
Zhejiang University