search
Back to results

WEI NASAL JET for The Sedation of Outpatient Upper Gastrointestinal Endoscopy

Primary Purpose

Peptic Ulcer, Gastric Cancer, Esophagus Cancer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
WEI NASAL JET
Nasopharyngeal airway without jet ventilator
Sponsored by
RenJi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Peptic Ulcer focused on measuring Sedation, Low pulse oximetry, Upper gastrointestinal endoscopy, WEI NASAL JET

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shanghai Tongji Hospital
  • Renji hospital, School of Medicine, Shanghai Jiaotong UniversityRecruiting
  • Shanghai Pudong New Area People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control group

Nasopharyngeal airway group

WEI NASAL JET group

Arm Description

Oxygen(2L/min) supplied with nasal catheter

Oxygen(2L/min) supplied directly through WEI NASAL JET without jet ventilator

Oxygen supplied through WEI NASAL JET with a manual jet ventilator

Outcomes

Primary Outcome Measures

Low pulse oximetry incidence

Secondary Outcome Measures

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.

Full Information

First Posted
April 26, 2015
Last Updated
May 1, 2015
Sponsor
RenJi Hospital
Collaborators
Shanghai Pudong New Area People's Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT02436018
Brief Title
WEI NASAL JET for The Sedation of Outpatient Upper Gastrointestinal Endoscopy
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
November 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RenJi Hospital
Collaborators
Shanghai Pudong New Area People's Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peptic Ulcer, Gastric Cancer, Esophagus Cancer, Oesophagitis, Hypoxia
Keywords
Sedation, Low pulse oximetry, Upper gastrointestinal endoscopy, WEI NASAL JET

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Oxygen(2L/min) supplied with nasal catheter
Arm Title
Nasopharyngeal airway group
Arm Type
Experimental
Arm Description
Oxygen(2L/min) supplied directly through WEI NASAL JET without jet ventilator
Arm Title
WEI NASAL JET group
Arm Type
Experimental
Arm Description
Oxygen supplied through WEI NASAL JET with a manual jet ventilator
Intervention Type
Device
Intervention Name(s)
WEI NASAL JET
Other Intervention Name(s)
Nasopharyngeal airway embedded with jet ventilation catheter
Intervention Description
Oxygen is supplied through WEI NASAL JET by a manual jet ventilator
Intervention Type
Device
Intervention Name(s)
Nasopharyngeal airway without jet ventilator
Intervention Description
Oxygen is supplied directly through WEI NASAL JET without jet ventilator
Primary Outcome Measure Information:
Title
Low pulse oximetry incidence
Time Frame
Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Secondary Outcome Measure Information:
Title
Other adverse events
Description
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.
Time Frame
Patients will be followed for the duration of hospital stay, an expected average of 2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diansan Su, Dr.
Phone
+862168383702
Email
diansansu@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diansan Su, Dr.
Organizational Affiliation
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai Tongji Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200065
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoqing Zhang, M.S.
Email
xq_820175@163.com
Facility Name
Renji hospital, School of Medicine, Shanghai Jiaotong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Qin, Master
Phone
+862168383702
Email
15921180801@163.com
First Name & Middle Initial & Last Name & Degree
Diansan Su, Dr.
First Name & Middle Initial & Last Name & Degree
Yi Qin, Master
Facility Name
Shanghai Pudong New Area People's Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lizhi Li, M.S.
Email
Fmlilizhi@sina.com.cn

12. IPD Sharing Statement

Citations:
PubMed Identifier
28974061
Citation
Qin Y, Li LZ, Zhang XQ, Wei Y, Wang YL, Wei HF, Wang XR, Yu WF, Su DS. Supraglottic jet oxygenation and ventilation enhances oxygenation during upper gastrointestinal endoscopy in patients sedated with propofol: a randomized multicentre clinical trial. Br J Anaesth. 2017 Jul 1;119(1):158-166. doi: 10.1093/bja/aex091.
Results Reference
derived

Learn more about this trial

WEI NASAL JET for The Sedation of Outpatient Upper Gastrointestinal Endoscopy

We'll reach out to this number within 24 hrs