Clinical trial NCT01453335: Percentage Venous Options in Pediatrics & Adults
Official title: Utilizing a Near Infrared Vein Visualization Device To Increase Peripheral Intravenous Access Targets in Pediatric & Adult Patients (% Venous Options)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Veins
Keywords: Veins
Catheter Segments
Vascular Access
VeinViewer Vision
Lead sponsor: Christie Medical Holdings, Inc.
Sponsor class: INDUSTRY
First posted: 2011-10-17
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Veins Identified with VeinViewer will be greater than those identified by sight or sight & palpation
timeFrame: Immediately after assessment-Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: HASBRO Children's Hospital
state: Rhode Island
Study officials:
affiliation: Hasbro Children's Hospital
name: Bruce M Becker, MD
role: PRINCIPAL_INVESTIGATOR
References: