WEI NASAL JET for The Sedation of Outpatient Upper Gastrointestinal Endoscopy

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02436018
• Other study ID #: RenJiH-20150308
• Status: Recruiting
• Phase: N/A
• First received: April 26, 2015
• Last updated: May 1, 2015
• Start date: March 2015
• Est. completion date: November 2016

Study information

• Verified date: May 2015
• Source: RenJi Hospital
• Contact: Diansan Su, Dr.
• Phone: +862168383702
• Email: diansansu[@]yahoo.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1800
• Est. completion date: November 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Esophagitis
• Esophagus Cancer
• Gastric Cancer
• Hypoxia
• Oesophagitis
• Peptic Ulcer

Intervention

Device:
• WEI NASAL JET
Oxygen is supplied through WEI NASAL JET by a manual jet ventilator
• Nasopharyngeal airway without jet ventilator
Oxygen is supplied directly through WEI NASAL JET without jet ventilator

Locations

Country	Name	City	State
China	Renji hospital, School of Medicine, Shanghai Jiaotong University	Shanghai	Shanghai
China	Shanghai Pudong New Area People's Hospital	Shanghai	Shanghai
China	Shanghai Tongji Hospital	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
RenJi Hospital	Shanghai Pudong New Area People's Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low pulse oximetry incidence		Patients will be followed for the duration of hospital stay, an expected average of 2 hours	No
Secondary	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	Yes