Percentage Venous Options in Pediatrics & Adults

Utilizing a Near Infrared Vein Visualization Device To Increase Peripheral Intravenous Access Targets in Pediatric & Adult Patients (% Venous Options)

VeinViewer® Vision will significantly increase the number of peripheral intravenous catheter access targets perceived by clinicians with experience in intravenous cannulation when compared to the number of access targets that these clinicians are able to visualize unaided or to palpate.

Study Overview

• Status: Completed
• Conditions: Veins

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Hasbro Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pediatric & Adult patients presenting at the Emergency Department that do not have an acute or critical medical illness or injury that required immediate evaluation and/or treatment.

Description

Pediatric arm

Inclusion Criteria:

• Age 17 years of age or younger,
• Intact skin, without rash,irritation, scarring, open abrasion or other injury in these sites.
• Parent or guardian is English speaking
• Pediatric patients 8 years older will be asked to provide assent
• Participant does not have an acute or critical medical illness or injury requiring immediate evaluation and/or treatment.

Exclusion Criteria:

• 18 years of age or older
• No intact upper extremities
• Patient has had current or recent (within 6 months) venous access in the arm that will be evaluated.
• Acute or critical illness or injury requiring immediate or urgent evaluation and treatment.

Adult arm:

Inclusion Criteria:

• Age 18 years or older,
• At least one intact upper extremity (intact from the base knuckle to the shoulder)
• Intact skin on the dorsum of the hand, the ventral forearm, and antecubital fossa, without rash, irritation, scarring, open abrasion or other injury in these sites.
• Participant does not have an acute or critical medical illness or injury requiring immediate evaluation and/or treatment.

Exclusion Criteria

• Younger than 18 years of age
• No intact upper extremities
• The participant does not have intact skin on the dorsum of the hand, the ventral forearm, and antecubital fossa, without rash, irritation, scarring, open abrasion or other injury preventing appropriate evaluation of these sites.
• Non-English speaking participant.
• Patient has had current or recent (within 6 months) venous access in the arm that will be evaluated.
• Acute or critical illness or injury requiring immediate or urgent evaluation and treatment.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Veins Identified with VeinViewer will be greater than those identified by sight or sight & palpation	Immediately after assessment-Day 1

Collaborators and Investigators

• Sponsor: Christie Medical Holdings, Inc.
• Investigators: Principal Investigator: Bruce M Becker, MD, Hasbro Children's Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: August 23, 2011
• First Submitted That Met QC Criteria: October 13, 2011
• First Posted (Estimate): October 17, 2011

Study Record Updates

• Last Update Posted (Estimate): December 23, 2011
• Last Update Submitted That Met QC Criteria: December 21, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Vascular Access; Veins; Catheter Segments; VeinViewer Vision
• Other Study ID Numbers: CP1001