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Assessment of Ultrasound-guided Inserted Peripheral Intravenous Catheter (ECLIPSE)

This study is currently recruiting participants.
Verified October 2012 by Prodimed SAS
Sponsor:
Information provided by (Responsible Party):
Prodimed SAS
ClinicalTrials.gov Identifier:
NCT01602133
First received: May 17, 2012
Last updated: October 24, 2012
Last verified: October 2012
History of Changes
  Purpose

Evaluate the safety and efficacy of an an ultrasound-guided inserted peripheral intravenous catheter during a period of seven days.


Condition Intervention
Venous Puncture
 Procedure: peripheral venous puncture

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Clinical Assessment of an Ultrasound-guided Inserted Peripheral Intravenous Catheter

Further study details as provided by Prodimed SAS:

Primary Outcome Measures:
  • length of use of the catheter measured in number of days [ Time Frame: seven days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • adverse event during the period of use of the catheter [ Time Frame: seven days ] [ Designated as safety issue: Yes ]
    extravasation and/or catheter removal before the end of the treatment and/or local complications (bleeding, neurologic trouble, venous thrombosis..)


Estimated Enrollment: 29
Study Start Date: June 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: one intervention arm Procedure: peripheral venous puncture
Ultrasound imaging of the arm is performed. If a suitable vein is identified, a percutaneous puncture is performed under ultrasound guidance. Then, an intravenous catheter is inserted according Seldinger method.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hospitalized patients with need of an intravenous therapy on peripheral line
  • Unsuccessful attempts at establishing a peripheral intravenous line by nurse
  • Age over 18 YO
  • Written informed consent obtained

Exclusion Criteria:

  • pregnant woman
  • local contra-indication for venous puncture
  • unconscious patient
  • need of intravenous therapy requiring central line
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01602133

Contacts
Contact: pascal meyer, MD pas.meyer@yahoo.fr

Locations
France
Centre Hospitalier Sud Francilien Recruiting
Corbeil-essonnes, France, 91 100
Sponsors and Collaborators
Prodimed SAS
Investigators
Principal Investigator: Pascal Meyer, MD Centre Hospitalier Sud Francilien- Corbeil- France
  More Information

No publications provided

Responsible Party: Prodimed SAS
ClinicalTrials.gov Identifier: NCT01602133     History of Changes
Other Study ID Numbers: 2011-A01570-41
Study First Received: May 17, 2012
Last Updated: October 24, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Keywords provided by Prodimed SAS:
venous puncture
seldinger technique
ultrasound guidance

ClinicalTrials.gov processed this record on May 16, 2013