WEI NASAL JET for The Sedation of Outpatient Upper Gastrointestinal Endoscopy

Not Applicable

• Conditions: Hypoxia; Esophagus Cancer; Gastric Cancer; Peptic Ulcer; Oesophagitis
• Interventions: Device: WEI NASAL JET; Device: Nasopharyngeal airway without jet ventilator

• Registration Number: NCT02436018
• Lead Sponsor: RenJi Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-04-26
• Status Verified: 2015-05
• Study First Submitted QC: 2015-05-01
• Last Update Submitted: 2015-05-01
• Study First Posted: 2015-05-06
• Last Update Posted: 2015-05-06
• Primary Completion: 2016-03
• Study Completion: 2016-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1800

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
WEI NASAL JET group	WEI NASAL JET	Oxygen supplied through WEI NASAL JET with a manual jet ventilator
Nasopharyngeal airway group	Nasopharyngeal airway without jet ventilator	Oxygen(2L/min) supplied directly through WEI NASAL JET without jet ventilator

Primary Outcome Measures

Name	Time	Method
Low pulse oximetry incidence	Patients will be followed for the duration of hospital stay, an expected average of 2 hours

Secondary Outcome Measures

Name	Time	Method
Other adverse events	Patients will be followed for the duration of hospital stay, an expected average of 2 hours	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.

Trial Locations

Locations (3)

Renji hospital, School of Medicine, Shanghai Jiaotong University; 🇨🇳 Shanghai, Shanghai, China

Shanghai Tongji Hospital; 🇨🇳 Shanghai, Shanghai, China

Shanghai Pudong New Area People's Hospital; 🇨🇳 Shanghai, Shanghai, China