Testing the Efficacy and Safety of the WEI Nasal Jet (WNJ)

Efficacy and Safety of the WEI Nasal Jet

Testing the efficacy and safety of the WEI Nasal Jet.

Study Overview

• Status: Completed
• Conditions: Complication of Surgical Procedure
• Intervention / Treatment: Device: Experimental group and control groupl

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.

• Study Type: Observational
• Enrollment (Actual): 49

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
wei group and control group; wei group(n=25) and control group(n=24)	Device: Experimental group and control groupl; JET; Other Names: Control; WEI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Zeyong Yang
• Collaborators: University of Pennsylvania
• Investigators: Principal Investigator: Zeyong Yang, MD, Ph.D, Shanghai Jiao Tong University School of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: July 3, 2013
• First Submitted That Met QC Criteria: December 6, 2013
• First Posted (Estimate): December 9, 2013

Study Record Updates

• Last Update Posted (Estimate): December 22, 2016
• Last Update Submitted That Met QC Criteria: December 21, 2016
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Wei JET
• Other Study ID Numbers: Wei JET