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Ultrasound-Guided Peripheral Intravenous Access by Critical Nurses. (IDECHO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02285712
Recruitment Status : Completed
First Posted : November 7, 2014
Last Update Posted : March 1, 2017
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Venous Catheterization Device: Vascular ultrasound system Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Contribution of Ultrasound for Peripheral Intravenous Catheter Placement by Intensive Care Nurses
Study Start Date : March 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017
Arms and Interventions
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Arm Intervention/treatment
No Intervention: Classical method of peripheral venous catheterization
Classical method will be applied only on arm and forearm.
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.
 Device: Vascular ultrasound system


Outcome Measures
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Primary Outcome Measures :
  1. number of peripheral venous catheterization attempts [ Time Frame: up to day 2 ]
    Each day, only 3 attempts are allowed


Secondary Outcome Measures :
  1. Number of central lines removed [ Time Frame: intraoperative ]
  2. central venous catheter dwell time [ Time Frame: intraoperative ]
    defined period between insertion and removal of the central venous line

  3. peripheral venous catheter dwell time [ Time Frame: intraoperative ]
    defined period between insertion and removal of the peripheral catheter with a maximum of 3 days.

  4. number of central line catheter related infection [ Time Frame: intraoperative ]
  5. number of central line catheter related colonization [ Time Frame: intraoperative ]
  6. Diameter of the inserted peripheral venous catheter [ Time Frame: day 0, or day 1 or day 2 ]
    at peripheral venous catheter insertion

  7. patient satisfaction [ Time Frame: intraoperative ]
    assessed by an analogic scale

  8. nurse satisfaction [ Time Frame: intraoperative ]
    assessed by a survey form

  9. Proportion of peripheral venous catheter successful placement [ Time Frame: at day 0, day 1, day 2 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02285712


Locations
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France
CHU Nancy - Service de Réanimation Médicale Brabois
Vandoeuvre-les-Nancy, France, 54511
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: Antoine Kimmoun, M.D Intensive care unit
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02285712    
Other Study ID Numbers: 2014-A01143-44
First Posted: November 7, 2014    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017
Keywords provided by Central Hospital, Nancy, France:
Peripheral venous catheter
ultrasound
nurse
Intensive Care Units