WEI NASAL JET for The Sedation of Outpatient Upper Gastrointestinal Endoscopy

May 1, 2015 updated by: diansan su, RenJi Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200065
        • Not yet recruiting
        • Shanghai Tongji Hospital
      • Shanghai, Shanghai, China, 200127
        • Recruiting
        • Renji Hospital, School of Medicine, Shanghai Jiaotong University
        • Contact:
        • Sub-Investigator:
          • Yi Qin, Master
      • Shanghai, Shanghai, China
        • Not yet recruiting
        • Shanghai Pudong New Area People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Oxygen(2L/min) supplied with nasal catheter
Experimental: Nasopharyngeal airway group
Oxygen(2L/min) supplied directly through WEI NASAL JET without jet ventilator
Device: Nasopharyngeal airway without jet ventilator
Oxygen is supplied directly through WEI NASAL JET without jet ventilator
Experimental: WEI NASAL JET group
Oxygen supplied through WEI NASAL JET with a manual jet ventilator
Device: WEI NASAL JET
Oxygen is supplied through WEI NASAL JET by a manual jet ventilator
Other Names:
  • Nasopharyngeal airway embedded with jet ventilation catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Low pulse oximetry incidence
Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
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
Time Frame: 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.
Patients will be followed for the duration of hospital stay, an expected average of 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Collaborators

Shanghai Tongji Hospital, Tongji University School of Medicine
Shanghai Pudong New Area People's Hospital

Investigators

  • Study Chair: Diansan Su, Dr., Renji Hospital, School of Medicine, Shanghai Jiaotong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

March 1, 2016

Study Completion (Anticipated)

November 1, 2016

Study Registration Dates

First Submitted

April 26, 2015

First Submitted That Met QC Criteria

May 1, 2015

First Posted (Estimate)

May 6, 2015

Study Record Updates

Last Update Posted (Estimate)

May 6, 2015

Last Update Submitted That Met QC Criteria

May 1, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RenJiH-20150308

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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