Clinical trial NCT05510388: HFNO Reduces Hypoxia During Sedated Gastroscopy or Colonoscopy in High Risk Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Cancer
Intestinal Cancer
Intestine Adenoma
Gastritis
Keywords: Gastroscopy
High-flow nasal oxygenation
Hypoxia
High-risk
Colonoscopy
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2022-08-22
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

1. Age ranging from 18 to 80, both sexes
2. Patients receiving selective gastroscopy or colonoscopy or gastroscopy and colonoscopy procedure
3. ASA Ⅲ\~Ⅳ
4. 18 kg/m2\<BMI\<28kg/m2
5. The anticipated operation time of the procedure shall be less than 30min.
6. Patients should clearly understand and voluntarily participate in the study, with signed informed consent.

Exclusion Criteria:

1. 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.
2. Patients diagnosed POCD
3. Patients clearly identified difficult airway
4. Patients with mechanical ventilation
5. Patients with acute respiratory infection and asthma
6. Patients with acute upper gastrointestinal hemorrhage accompanied by shock, severe anemia, gastrointestinal obstruction accompanied by retention of gastric contents
7. Patients with aortic stenosis and carotid stenosis
8. Patients allergic to sedatives such as propofol
9. Patients without civil capacity such as cognitive dysfunction

Primary outcomes:
measure: The incidence of hypoxia
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Secondary outcomes:
measure: The incidence of severe hypoxia
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
measure: The incidence of subclinical respiratory depression
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
measure: Other adverse events evaluated by the tool of World SIVA
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
measure: Complications related to high-flow nasal cannula
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The Second Hospital Affiliated to Chongqing Medical University
state: Chongqing
city: Zhengzhou
country: China
facility: Henan Provincial people's hospital
state: Henan
Study officials:
References: