Video Documentation of Localized Complications

Vascular Access Clinical Trial

Official title:

Video Documentation of Localized Complications in IV Cannulation Using Near-Infrared Technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01453322
• Other study ID #: CP1009
• Status: Completed
• Phase: N/A
• First received: October 12, 2011
• Last updated: October 17, 2011
• Start date: September 2011
• Est. completion date: September 2011

Study information

• Verified date: October 2011
• Source: Christie Medical Holdings, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The objective of this study is to confirm and document that with the use of a FDA Class I exempt near infrared device, VeinViewer® Vision that is hands-free and can be used for healthy adult volunteers with varying skin types to assist in the improved visualization, it is possible to film, analyze and document PIV localized complications and venous flow and refill.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must be 18 years of age or older

• Must be considered in good health by investigator

• Must be able to read and understand English

Exclusion Criteria

• Less than 18 years of age

• Known allergy to Heparin

• History of HIT (Heparin-induced thrombocytopenia)

• Unable to read and understand English

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Vascular Access

Locations

Country	Name	City	State
United States	Key Biologics LLC	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Christie Medical Holdings, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Valve and Refill Confirmation	Using VeinViewer, the clinician will be able to view valves and refill. It will be confirmed using Ultrasound.	Immediately after flush-Day 1	No
Secondary	Video Documentation of localized vascular access complications	Using VeinViewer, the user will be able to detect hematomas and infiltrations.	Immediately after attempt-Day 1	No