NCT01453335

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 17, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

December 23, 2011

Status Verified

December 1, 2011

Enrollment Period

2 months

First QC Date

August 23, 2011

Last Update Submit

December 21, 2011

Conditions

Keywords

VeinsCatheter SegmentsVascular AccessVeinViewer Vision

Outcome Measures

Primary Outcomes (1)

  • Number of Veins Identified with VeinViewer will be greater than those identified by sight or sight & palpation

    Immediately after assessment-Day 1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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:
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HASBRO Children's Hospital

Providence, Rhode Island, 02903, United States

Location

Study Officials

  • Bruce M Becker, MD

    Hasbro Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2011

First Posted

October 17, 2011

Study Start

June 1, 2011

Primary Completion

August 1, 2011

Study Completion

December 1, 2011

Last Updated

December 23, 2011

Record last verified: 2011-12

Locations