WEI NASAL JET for The Sedation of Outpatient Upper Gastrointestinal Endoscopy

Study Overview
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Brief Summary
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Low pulse oximetry is the most common adverse events during sedation for upper gastrointestinal endoscopy. The main reason is the glossoptosis after sedation. In present study a new designed nasopharyngeal airway embedded with jet ventilation catheter(WEI NASAL JET) will be utilized in order to reduce the hypoxia. At the same time the safety will be evaluated.

Official Title
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Safety and Efficacy Evaluation of The Nasopharyngeal Airway Embedded With Jet Ventilation Catheter(WEI NASAL JET) Applied for The Sedation of Outpatient Upper Gastrointestinal Endoscopy

Conditions
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Peptic Ulcer, Gastric Cancer, Esophagus Cancer, Oesophagitis, Hypoxia

Intervention / Treatment
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* Device: WEI NASAL JET
* Device: Nasopharyngeal airway without jet ventilator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients undergoing upper gastrointestinal endoscopy age over 18 years old Signed informed consent form Exclusion Criteria: a blood coagulation dysfunction or have a tendency of nose bleeding a clear diagnosis of heart disease (heart failure, angina, myocardial infarction, arrhythmia, etc.) a clear diagnosis of lung disease (asthma, chronic obstructive pulmonary disease, pulmonary embolism, pulmonary edema, lung cancer) pregnant liver disease kidney disease increase in intracranial pressure emergency operation multiple trauma American Society of Anesthesiologists (ASA) Physical Status classification above IV with mouth, nose and throat infection

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: Nasopharyngeal airway group<br>Oxygen(2L/min) supplied directly through WEI NASAL JET without jet ventilator | Device: Nasopharyngeal airway without jet ventilator<br>* Oxygen is supplied directly through WEI NASAL JET without jet ventilator<br>|
| Experimental: WEI NASAL JET group<br>Oxygen supplied through WEI NASAL JET with a manual jet ventilator | Device: WEI NASAL JET<br>* Oxygen is supplied through WEI NASAL JET by a manual jet ventilator<br>* Other names: Nasopharyngeal airway embedded with jet ventilation catheter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low pulse oximetry incidence |  | 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 |
| --- | --- | --- |
| Other adverse events | The adverse events according to the Adverse event reporting tool of the world SIVA International Sedation Task Force during upper gastrointestinal endoscopy will be recorded. Adverse events associated with jet ventilation also be recorded. | 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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Sedation, Low pulse oximetry, Upper gastrointestinal endoscopy, WEI NASAL JET