- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01020461
Evaluation of Accuvein in Adult Patients
September 22, 2016 updated by: Hopital Foch
Evaluation of Accuvein for Blood Sampling and for Intravenous Catheter Placement in Adult Patients
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
522
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Suresnes, France, 92151
- Hopital FOCH
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- adults requiring a venous blood sampling or the placement of a venous peripheral catheter
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Venous blood sampling
To use Accuvein to improve the effectiveness of venous blood sampling
|
Accuvein will be used to facilitate venous blood sampling
Accuvein will be used to facilitate peripheral IV catheter placement
|
|
EXPERIMENTAL: Peripheral IV catheter placement
To use Accuvein to improve the effectiveness of placing peripheral IV catheter
|
Accuvein will be used to facilitate venous blood sampling
Accuvein will be used to facilitate peripheral IV catheter placement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Time to successful blood sampling or to successful placement of IV catheter
Time Frame: one hour
|
one hour
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of attempts required
Time Frame: Immediately after attempts
|
Immediately after attempts
|
|
Pain
Time Frame: Immediately after attempts
|
Immediately after attempts
|
|
Increases in the ease and efficiency of venous cannulation perceived by the operator)
Time Frame: Immediately after attempts
|
Immediately after attempts
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (ACTUAL)
April 1, 2013
Study Completion (ACTUAL)
April 1, 2013
Study Registration Dates
First Submitted
November 22, 2009
First Submitted That Met QC Criteria
November 23, 2009
First Posted (ESTIMATE)
November 25, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
September 23, 2016
Last Update Submitted That Met QC Criteria
September 22, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 2009/43
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.