NCT02005406

Brief Summary

Testing the efficacy and safety of the WEI Nasal Jet.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2012

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2013

Completed
5 months until next milestone

First Posted

Study publicly available on registry

December 9, 2013

Completed
Last Updated

December 22, 2016

Status Verified

December 1, 2013

Enrollment Period

9 months

First QC Date

July 3, 2013

Last Update Submit

December 21, 2016

Conditions

Keywords

Wei JET

Outcome Measures

Primary Outcomes (1)

  • lowest SaO2 in Wei JET group

    Compare with Control group,there was no significant difference in lowest SaO2 in Wei JET group.

    2 second

Study Arms (1)

wei group and control group

wei group(n=25) and control group(n=24)

Device: Experimental group and control groupl

Interventions

JET

Also known as: WEI, Control
wei group and control group

Eligibility Criteria

Age22 Years - 58 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Suggested patient inclusion criteria: Patients receiving various types of surgeries under sedation, especially for procedures of colonoscopy, upper gastrointestinal endoscopy, endoscopic retrograde cholangiopancreatography (ERCP) cystoscopy and other brief surgeries you are interested in the study.

You may qualify if:

  • Patients receiving various types of surgeries under sedation, especially for procedures of colonoscopy, upper gastrointestinal endoscopy, endoscopic retrograde cholangiopancreatography (ERCP) cystoscopy and other brief surgeries you are interested in the study.

You may not qualify if:

  • Patients with coagulopathy and tendency of nose bleeding.
  • Patients with any diagnosed cardiac diseases (e.g. cardiac failure, angina, MI, cardiac arrhythmia. etc.)
  • Patients with any diagnosed pulmonary disease (e.g. asthma, COPD, pulmonary embolism, pulmonary edema etc.)
  • Pregnant patients
  • Patients with liver failure
  • Patients with kidney failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Yang ZY, Meng Q, Xu YH, Wang JW, Yu DS, Wei HF. Supraglottic jet oxygenation and ventilation during colonoscopy under monitored anesthesia care: a controlled randomized clinical trial. Eur Rev Med Pharmacol Sci. 2016;20(6):1168-73.

Biospecimen

Retention: SAMPLES WITHOUT DNA

•Patients receiving various types of surgeries under sedation, especially for procedures of colonoscopy, upper gastrointestinal endoscopy, endoscopic retrograde cholangiopancreatography (ERCP) cystoscopy and other brief surgeries you are interested in the study.

Study Officials

  • Zeyong Yang, MD, Ph.D

    Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Shanghai Jiaotong University

Study Record Dates

First Submitted

July 3, 2013

First Posted

December 9, 2013

Study Start

June 1, 2012

Primary Completion

March 1, 2013

Study Completion

April 1, 2013

Last Updated

December 22, 2016

Record last verified: 2013-12