HFNO Reduces Hypoxia During Sedated Gastroscopy or Colonoscopy in High Risk Patients

Study Overview
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Brief Summary
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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.

Official Title
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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
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Gastric Cancer, Intestinal Cancer, Intestine Adenoma, Gastritis

Intervention / Treatment
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* Device: High-flow nasal cannula oxygenation
* Device: Regular nasal cannula oxygenation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ranging from 18 to 80, both sexes Patients receiving selective gastroscopy or colonoscopy or gastroscopy and colonoscopy procedure ASA Ⅲ Ⅳ 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-flow nasal cannula oxygenation group<br> | Device: High-flow nasal cannula oxygenation<br>* The patients receive oxygen flow of 6L/min for preoxygenation with an high-flow canular oxygenation device before losing of conscious. Then, the oxygen flow is adjusted to 60L/min with the oxygen concentration of 100% and the temperature of 37℃ until the end of procedure.<br>|
| Active Comparator: Regular nasal cannula oxygenation group<br> | Device: Regular nasal cannula oxygenation<br>* The patients receive an oxygen flow of 6L/min for preoxygenation with a disposal regular nasal cannula until the end of procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of hypoxia | Hypoxia refers to 75%≤SpO2<90%,<60S | Patients will be followed for the duration of hospital stay, an expected average of 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of severe hypoxia | Severe hypoxia refers to SpO2<75% lasting for any time, or 75%≤SpO2<90%, ≥60s | Patients will be followed for the duration of hospital stay, an expected average of 2 hours | 
| The incidence of subclinical respiratory depression | Subclinical respiratory depression refers to 90%≤ SpO2<95% | 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 | 
| Complications related to high-flow nasal cannula |  | Patients will be followed for the duration of hospital stay, an expected average of 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastroscopy, High-flow nasal oxygenation, Hypoxia, High-risk, Colonoscopy