Percentage Venous Options in Pediatrics & Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christie Medical Holdings, Inc.
ClinicalTrials.gov Identifier:
NCT01453335
First received: August 23, 2011
Last updated: December 21, 2011
Last verified: December 2011
  Purpose

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.


Condition
Veins

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Utilizing a Near Infrared Vein Visualization Device To Increase Peripheral Intravenous Access Targets in Pediatric & Adult Patients (% Venous Options)

Further study details as provided by Christie Medical Holdings, Inc.:

Primary Outcome Measures:
  • Number of Veins Identified with VeinViewer will be greater than those identified by sight or sight & palpation [ Time Frame: Immediately after assessment-Day 1 ] [ Designated as safety issue: No ]

Enrollment: 300
Study Start Date: June 2011
Study Completion Date: December 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01453335

Locations
United States, Rhode Island
HASBRO Children's Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Christie Medical Holdings, Inc.
Investigators
Principal Investigator: Bruce M Becker, MD Hasbro Children's Hospital
  More Information

No publications provided

Responsible Party: Christie Medical Holdings, Inc.
ClinicalTrials.gov Identifier: NCT01453335     History of Changes
Other Study ID Numbers: CP1001
Study First Received: August 23, 2011
Last Updated: December 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Christie Medical Holdings, Inc.:
Veins
Catheter Segments
Vascular Access
VeinViewer Vision

ClinicalTrials.gov processed this record on October 29, 2014