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WEI NASAL JET for The Sedation of Outpatient Upper Gastrointestinal Endoscopy

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02436018
Enrollment
1800
Registered
2015-05-06
Start date
2015-03-31
Completion date
2016-11-30
Last updated
2015-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Sedation, Low pulse oximetry, Upper gastrointestinal endoscopy, WEI NASAL JET

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.

Interventions

DEVICEWEI NASAL JET

Oxygen is supplied through WEI NASAL JET by a manual jet ventilator

DEVICENasopharyngeal airway without jet ventilator

Oxygen is supplied directly through WEI NASAL JET without jet ventilator

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Low pulse oximetry incidencePatients will be followed for the duration of hospital stay, an expected average of 2 hours

Secondary

MeasureTime frameDescription
Other adverse eventsPatients will be followed for the duration of hospital stay, an expected average of 2 hoursThe 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.

Countries

China

Contacts

Primary ContactDiansan Su, Dr.
diansansu@yahoo.com+862168383702

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026