Evaluation of Accuvein in Adult Patients

This study has been terminated.
(Arm "placement periph iv cath" COMPLETED - Arm "blood sampling" : study will not be performed because of the results of the arm "placement periph. iv cath")
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT01020461
First received: November 22, 2009
Last updated: April 17, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Catheterization
Device: Accuvein
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Accuvein for Blood Sampling and for Intravenous Catheter Placement in Adult Patients

Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • Time to successful blood sampling or to successful placement of IV catheter [ Time Frame: one hour ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of attempts required [ Time Frame: Immediately after attempts ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: Immediately after attempts ] [ Designated as safety issue: No ]
  • Increases in the ease and efficiency of venous cannulation perceived by the operator) [ Time Frame: Immediately after attempts ] [ Designated as safety issue: No ]

Enrollment: 522
Study Start Date: January 2010
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Venous blood sampling
To use Accuvein to improve the effectiveness of venous blood sampling
Device: Accuvein
Accuvein will be used to facilitate venous blood sampling
Experimental: Peripheral IV catheter placement
To use Accuvein to improve the effectiveness of placing peripheral IV catheter
Device: Accuvein
Accuvein will be used to facilitate peripheral IV catheter placement

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01020461

Locations
France
Hôpital Foch
Suresnes, France, 92151
Sponsors and Collaborators
Hopital Foch
Investigators
Study Chair: Marc Fischler, MD Hôpital Foch
  More Information

No publications provided

Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT01020461     History of Changes
Other Study ID Numbers: 2009/43
Study First Received: November 22, 2009
Last Updated: April 17, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on April 22, 2014