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Percentage Venous Options in Pediatrics & Adults

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ClinicalTrials.gov Identifier: NCT01453335
Recruitment Status : Completed
First Posted : October 17, 2011
Last Update Posted : December 23, 2011
Sponsor:
Information provided by (Responsible Party):
Christie Medical Holdings, Inc.

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.

Condition or disease
Veins

Study Type : Observational
Actual Enrollment : 300 participants
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)
Study Start Date : June 2011
Actual Primary Completion Date : August 2011
Actual Study Completion Date : December 2011



Primary Outcome Measures :
  1. Number of Veins Identified with VeinViewer will be greater than those identified by sight or sight & palpation [ Time Frame: Immediately after assessment-Day 1 ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Christie Medical Holdings, Inc.
ClinicalTrials.gov Identifier: NCT01453335     History of Changes
Other Study ID Numbers: CP1001
First Posted: October 17, 2011    Key Record Dates
Last Update Posted: December 23, 2011
Last Verified: December 2011

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