Percentage Venous Options in Pediatrics & Adults

Veins Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01453335
• Other study ID #: CP1001
• Status: Completed
• Phase: N/A
• First received: August 23, 2011
• Last updated: December 21, 2011
• Start date: June 2011
• Est. completion date: December 2011

Study information

• Verified date: December 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Veins

Locations

Country	Name	City	State
United States	HASBRO Children's Hospital	Providence	Rhode Island

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	Number of Veins Identified with VeinViewer will be greater than those identified by sight or sight & palpation		Immediately after assessment-Day 1	No