Video Documentation of Localized Complications

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01453322

Enrollment

Registered

2011-10-17

Start date

2011-09-30

Completion date

2011-09-30

Last updated

2011-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vascular Access

Keywords

Veins, Vascular Access, IV complications, VeinViewer Vision

Brief 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Valve and Refill Confirmation	Immediately after flush-Day 1	Using VeinViewer, the clinician will be able to view valves and refill. It will be confirmed using Ultrasound.

Secondary

Measure	Time frame	Description
Video Documentation of localized vascular access complications	Immediately after attempt-Day 1	Using VeinViewer, the user will be able to detect hematomas and infiltrations.

Countries

United States

Outcome results