- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02285712
Ultrasound-Guided Peripheral Intravenous Access by Critical Nurses. (IDECHO)
February 28, 2017 updated by: Central Hospital, Nancy, France
Contribution of Ultrasound for Peripheral Intravenous Catheter Placement by Intensive Care Nurses
Peripheral intravenous access is a major intervention in patients admitted to an intensive care unit.
Systematically performed by nurses, it is also an essential intervention when the central venous access has to be removed.
However, in the intensive care unit, patient centered-characteristics such as previous history of intravenous drug abuse, obesity, history of multiple vascular punctures or fluid overload most often affect the success rate of this procedure.
For these patients, failure consequences are numerous: 1) delayed discharge from the intensive care unit, 2) increased pain and dissatisfaction, 3) increased incidence of catheter-related bloodstream infections.
The use of ultrasound has gained increasing popularity particularly for obtaining central venous access.
We hypothesize that, among trained nurses, ultrasound-guided peripheral venous access could represent an attractive alternative compared to the traditional anatomical method in order to increase the success rate.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
114
Phase
- Not Applicable
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
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Vandoeuvre-les-Nancy, France, 54511
- CHU Nancy - Service de Réanimation Médicale Brabois
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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:
- patient admitted in ICU
- patient not able to express his opposition
- central venous access that need to be removed
- need for a peripheral venous access
- no clinical instability
- no visible superficial vein due to: BMI> 30, fluid overload, previous history of IV drug abuse, previous history of chemotherapy ,
Exclusion Criteria:
- patient < 18 yo
- pregnancy
- patient under protective supervision
- need for a central venous access
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Classical method of peripheral venous catheterization
Classical method will be applied only on arm and forearm.
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Experimental: Ultrasound guided peripheral venous catheterization
Nurse will use a vascular ultrasound system to orient the catheter toward the peripheral vein.
Ultrasound method will be applied only on arm and forearm.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of peripheral venous catheterization attempts
Time Frame: up to day 2
|
Each day, only 3 attempts are allowed
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up to day 2
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of central lines removed
Time Frame: intraoperative
|
intraoperative
|
|
central venous catheter dwell time
Time Frame: intraoperative
|
defined period between insertion and removal of the central venous line
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intraoperative
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peripheral venous catheter dwell time
Time Frame: intraoperative
|
defined period between insertion and removal of the peripheral catheter with a maximum of 3 days.
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intraoperative
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number of central line catheter related infection
Time Frame: intraoperative
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intraoperative
|
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number of central line catheter related colonization
Time Frame: intraoperative
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intraoperative
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Diameter of the inserted peripheral venous catheter
Time Frame: day 0, or day 1 or day 2
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at peripheral venous catheter insertion
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day 0, or day 1 or day 2
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patient satisfaction
Time Frame: intraoperative
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assessed by an analogic scale
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intraoperative
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nurse satisfaction
Time Frame: intraoperative
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assessed by a survey form
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intraoperative
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Proportion of peripheral venous catheter successful placement
Time Frame: at day 0, day 1, day 2
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at day 0, day 1, day 2
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Antoine Kimmoun, M.D, Intensive care unit
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
March 1, 2015
Primary Completion (Actual)
January 1, 2017
Study Completion (Actual)
January 1, 2017
Study Registration Dates
First Submitted
November 5, 2014
First Submitted That Met QC Criteria
November 6, 2014
First Posted (Estimate)
November 7, 2014
Study Record Updates
Last Update Posted (Actual)
March 1, 2017
Last Update Submitted That Met QC Criteria
February 28, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 2014-A01143-44
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.
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