Assessment of Ultrasound-guided Inserted Peripheral Intravenous Catheter

Venous Puncture Clinical Trial

— ECLIPSE  

Official title:

A Clinical Assessment of an Ultrasound-guided Inserted Peripheral Intravenous Catheter

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01602133
• Other study ID #: 2011-A01570-41
• Status: Recruiting
• Phase: N/A
• First received: May 17, 2012
• Last updated: October 24, 2012
• Start date: June 2012
• Est. completion date: June 2014

Study information

• Verified date: October 2012
• Source: Prodimed SAS
• Contact: pascal meyer, MD
• Email: pas.meyer[@]yahoo.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 29
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Venous Puncture

Intervention

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.

Locations

Country	Name	City	State
France	Centre Hospitalier Sud Francilien	Corbeil-essonnes

Sponsors (1)

Lead Sponsor	Collaborator
Prodimed SAS

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	length of use of the catheter measured in number of days		seven days	No
Secondary	adverse event during the period of use of the catheter	extravasation and/or catheter removal before the end of the treatment and/or local complications (bleeding, neurologic trouble, venous thrombosis..)	seven days	Yes