Evaluation of Accuvein in Adult Patients

• Sponsor: Hopital Foch (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01020461
• Collaborator: (none)
• Enrollment: 522
• Location: 1
• Arms: 2
• Duration (Months): 39
• Patients Per Site Per Month: 13.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Catheterization	Device: Accuvein; Device: Accuvein	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 522 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of Accuvein for Blood Sampling and for Intravenous Catheter Placement in Adult Patients
• Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Apr 1, 2013
• Actual Study Completion Date: Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Time to successful blood sampling or to successful placement of IV catheter [one hour]

Secondary Outcome Measures

1. Number of attempts required [Immediately after attempts]

2. Pain [Immediately after attempts]

3. Increases in the ease and efficiency of venous cannulation perceived by the operator) [Immediately after attempts]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• none

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Foch	Suresnes		France	92151

Sponsors and Collaborators

• Hopital Foch

Investigators

• Study Chair: Marc Fischler, MD, Hôpital Foch

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hopital Foch
• ClinicalTrials.gov Identifier: NCT01020461
• Other Study ID Numbers: 2009/43
• First Posted: Nov 25, 2009
• Last Update Posted: Sep 23, 2016
• Last Verified: Sep 1, 2016

Study Results

No Results Posted as of Sep 23, 2016