Effect of HFNC on Incidence of Hypoxia During Sedated Gastrointestinal Endoscopy in Critical Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High-flow nasal catheter oxygen, regular nasal catheter oxygen.
- Who it may be relevant to
- Registry conditions: Liver Cirrhosis, Polyps of Colon, Gastrointestinal Dysfunction. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of High Flow Nasal Cannula Oxygenation on Incidence of Hypoxia During Sedated Gastrointestinal Endoscopy in Critical Patients: A Multicentre Randomised Controlled Trial
Overview
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.
Interventions
- Device High-flow nasal catheter oxygen
Before induction of anesthesia, connect the Airvo2 (HFNC high flow device) special nasal cannula to inhale oxygen, and preoxygenate with an oxygen flow rate of 6L /min. After induction of anesthesia, adjust the oxygen flow rate to 60L /min, oxygen concentration 100%, oxygen temperature 37℃ until the end of gastrointestinal endoscopy. - Device regular nasal catheter oxygen
Before anesthesia induction, a disposable nasal catheter oxygen inhalation device (covered by HFNC nasal catheter and blinded to the patient) was connected to an oxygen source for pre-oxygen inhalation, 6L/min. After induction of anesthesia, oxygen was continued for 6L/min until the end of gastroenteroscopy.
Primary outcome measures
- Incidence of hypoxia [Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours]
Secondary outcome measures (2)
- Incidence of severe hypoxia [Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours]
- Incidence of subclinical respiratory depression [Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
China · 3 centers
- Shenzhen Hospital of Southern Medical University — Shenzhen
- Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center — Shenzhen
- The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou
Identifiers
NCT: NCT07252102 · ZJU2025C036