NCT02015845

Brief Summary

The objective of this study is to evaluate the effectiveness of Accuvein to facilitate placement of peripheral intravenous catheters in obese patients. 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, 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
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2013

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

November 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 5, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 19, 2013

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 19, 2017

Status Verified

May 1, 2017

Enrollment Period

3.5 years

First QC Date

December 5, 2013

Last Update Submit

May 18, 2017

Conditions

Primary Care

Outcome Measures

Primary Outcomes (1)

  • Percentage of success of the first vein puncture

    Successful successful placement of IV catheter

    one hour

Secondary Outcomes (1)

  • Score of evaluation of the device

    one hour

Study Arms (2)

Accuvein

EXPERIMENTAL

Use of Accuvein to facilitate placement of peripheral intravenous catheters in obese patients

Device: Accuvein

Routine technique

ACTIVE COMPARATOR

Routine technique used to insert a peripheral intravenous catheters in obese patients.

Device: Routine technique

Interventions

AccuveinDEVICE
Accuvein
Routine techniqueDEVICE

Placement of peripheral intravenous catheters using the routine technique

Routine technique

Eligibility Criteria

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

You may qualify if:

  • obese adults ( BMI equal or greater 35) requiring a venous blood sampling or the placement of a venous peripheral catheter

You may not qualify if:

  • pregnant woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Hospitalier Franco-Britannique

Levallois-Perret, Hauts de Seine, 92300, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2013

First Posted

December 19, 2013

Study Start

November 1, 2013

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

May 19, 2017

Record last verified: 2017-05

Locations

FR(1)