NCT01020461

Brief Summary

The objective of this study is to evaluate the effectiveness of Accuvein to facilitate venous blood sampling and placement of peripheral intravenous catheters in adults. This clinical protocol is designed to determine whether using Accuvein increases the ease and efficiency of venous cannulation (as perceived by the operator), decreases the time to effective cannulation, decreases the number of sticks, and decreases the patient's perception of the pain.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
522

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2010

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

November 22, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 25, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

September 23, 2016

Status Verified

September 1, 2016

Enrollment Period

3.2 years

First QC Date

November 22, 2009

Last Update Submit

September 22, 2016

Conditions

Catheterization

Outcome Measures

Primary Outcomes (1)

  • Time to successful blood sampling or to successful placement of IV catheter

    one hour

Secondary Outcomes (3)

  • Number of attempts required

    Immediately after attempts

  • Pain

    Immediately after attempts

  • Increases in the ease and efficiency of venous cannulation perceived by the operator)

    Immediately after attempts

Study Arms (2)

Venous blood sampling

EXPERIMENTAL

To use Accuvein to improve the effectiveness of venous blood sampling

Device: Accuvein

Peripheral IV catheter placement

EXPERIMENTAL

To use Accuvein to improve the effectiveness of placing peripheral IV catheter

Device: Accuvein

Interventions

AccuveinDEVICE

Accuvein will be used to facilitate venous blood sampling

Venous blood sampling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults requiring a venous blood sampling or the placement of a venous peripheral catheter

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Foch

Suresnes, France, 92151, France

Location

Related Publications (1)

  • Aulagnier J, Hoc C, Mathieu E, Dreyfus JF, Fischler M, Le Guen M. Efficacy of AccuVein to facilitate peripheral intravenous placement in adults presenting to an emergency department: a randomized clinical trial. Acad Emerg Med. 2014 Aug;21(8):858-63. doi: 10.1111/acem.12437.

    PMID: 25176152DERIVED

Study Officials

  • Marc Fischler, MD

    Hôpital Foch

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2009

First Posted

November 25, 2009

Study Start

January 1, 2010

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

September 23, 2016

Record last verified: 2016-09

Locations

FR(1)