ECLIPSE: Assessment of Ultrasound-guided Inserted Peripheral Intravenous Catheter

Sponsor

Prodimed SAS (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01602133

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Venous Puncture	Procedure: peripheral venous puncture	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

29 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Official Title:

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

Study Start Date :

Jun 1, 2012

Anticipated Primary Completion Date :

Jun 1, 2014

Anticipated Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

length of use of the catheter measured in number of days [seven days]

Secondary Outcome Measures

adverse event during the period of use of the catheter [seven days]
extravasation and/or catheter removal before the end of the treatment and/or local complications (bleeding, neurologic trouble, venous thrombosis..)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Sud Francilien	Corbeil-essonnes		France	91 100

Sponsors and Collaborators

Prodimed SAS

Investigators

Principal Investigator: Pascal Meyer, MD, Centre Hospitalier Sud Francilien- Corbeil- France

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Prodimed SAS

ClinicalTrials.gov Identifier:

NCT01602133

Other Study ID Numbers:

2011-A01570-41

First Posted:

May 18, 2012

Last Update Posted:

Oct 25, 2012

Last Verified:

Oct 1, 2012

Keywords provided by Prodimed SAS

venous puncture

seldinger technique

ultrasound guidance

Study Results

No Results Posted as of Oct 25, 2012