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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Prodimed SAS.
Recruitment status was  Recruiting
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
  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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 19, 2014