Testing the Efficacy and Safety of the WEI Nasal Jet | NCT02005406

Studies
Testing the Efficacy and Safety of the WEI Nasal Jet

NCT02005406

Sponsor

Zeyong Yang

Status

Completed

Last Update Posted

Dec 22, 2016Estimated

Enrollment

49Actual

Phase

Not provided

Conditions

Complication of Surgical Procedure

Interventions

Experimental group and control groupl

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Mar 2013Actual

Completion Date

Apr 2013Actual

First Submitted Date

Jul 3, 2013

First Submission Date that Met QC Criteria

Dec 6, 2013

First Posted Date

Dec 9, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 21, 2016

Last Update Posted Date

Dec 22, 2016Estimated

Name	Class
University of Pennsylvania	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Testing the efficacy and safety of the WEI Nasal Jet.

Detailed Description

This is only initial thought and suggestions from the inventor Dr. Huafeng Wei. Principal investigator from each medical center interested in testing this new device should design their own clinical trials based on patient population and their own ideas for clinical trials. Just remind you that patient safety is number one and try all efforts to minimize patient risks during your clinical study.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

49Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
wei group and control group		wei group(n=25) and control group(n=24)	Device: Experimental group and control groupl

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Experimental group and control groupl	Device	JET	wei group and control group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
lowest SaO2 in Wei JET group	Compare with Control group,there was no significant difference in lowest SaO2 in Wei JET group.	2 second

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

58 Years

Standard Ages

Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zeyong Yang, MD, Ph.D	Shanghai Jiao Tong University School of Medicine	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27049273	Derived	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.