High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Gastroscopy Sedated by Propofol

Study Overview
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Brief Summary
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Hypoxia is the most common adverse events during sedated gastroscopy. In present study, high-flow nasal cannula oxygenation will be utilized in order to reduce the hypoxia. At the same time the feasibility and safety will be evaluated.

Official Title
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High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Gastroscopy Sedated by Propofol: a Randomized Multicentre Clinical Trial

Conditions
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Hypoxia, Gastric Cancer, Esophagus Cancer, Adverse Event

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients undergoing gastroscope age over 18 years old Signed informed consent form Exclusion Criteria: Coagulation disorders or a tendency of nose bleeding; An episode/exacerbation of congestive heart failure (CHF) that requires a change in medication, diet or hospitalization from any cause in the last 6 months; Severe aortic stenosis or mitral stenosis; Cardiac surgery involving thoracotomy (e.g., coronary artery bypass graft (CABG), valve replacement surgery) in the last 6 months; Acute myocardial infarction in the last 6 months; Acute arrhythmia (including any tachycardia - or bradycardia) with hemodynamic instability; Diagnosed chronic obstructive pulmonary disease or current other acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy); Increased intracranial pressure; ASA >III; Mouth, nose, or throat infection; Fever, defined as core body temperature > 37.5oC ; Pregnancy, breastfeeding or positive pregnancy test Emergency procedure

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| No Intervention: Control group<br>Oxygen(2L/min) supplied with nasal catheter | |
| Experimental: High-flow nasal cannula group<br>Oxygen(up to 60L/min) supplied with high-flow nasal cannula | Device: High-flow nasal cannula oxygenation<br>* Oxygen is supplied with a high-flow nasal cannula oxygenation device，the flow is up to 60L/min<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hypoxia | (75% ≤ SpO2 < 90% for <60 s) | 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 |
| --- | --- | --- |
| Incidence of subclinical respiratory depression | (90% ≤ SpO2 < 95%) | Patients will be followed for the duration of hospital stay, an expected average of 2 hours | 
| Incidence of severe hypoxia | (SpO2 < 75% for any duration or 75% ≤ SpO2 < 90% for >/=60 s) | Patients will be followed for the duration of hospital stay, an expected average of 2 hours | 
| Other adverse events | Other adverse events include other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force and HFNC supportive oxygen therapy-related adverse events. | 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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Hypoxia, Gastroscope, High-flow nasal cannula