Status:
COMPLETED
Compact Closed System Versus Mounted Open System (COSMOS)
Lead Sponsor:
Hospital San Carlos, Madrid
Collaborating Sponsors:
Foundation for Biomedical Research and Innovation
Conditions:
Catheterization, Peripheral
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to investigate, in a prospective and randomized fashion, the clinical performance of a closed intravenous system versus an open conventional one, with respect to ease of h...
Detailed Description
Study Design: This study has a prospective, open, randomized, unblinded, group-sequential design. Study initiation will be proceeded by a program of education and training for all the nurse participa...
Eligibility Criteria
Inclusion
- Patient admitted to one of the participating units: H2N (Internal Medicine), H3N (Urology, Surgery, Trauma) and H3S (General Surgery)
- Age equal to or greater than 18 years
- Clinical need for a peripheral catheter of gauge size 18 G to 22 G for an anticipated period of 24 hours or greater
- Informed verbal consent before a witness (family relative or a health care professional employed by the hospital)
Exclusion
- Minor (\<18 years old)
- Inability to understand the information regarding study purpose and procedure
- Absence of witnessed verbal informed consent
- Participation in any other study
- IV placed under emergency conditions
- Presence of a Central Venous Catheter or PICC line
- Presence of a fever of 38º C of more at the time of inclusion
- Anticipated use of the catheter and/or stay in the unit of less than 24 hours
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT00665886
Start Date
March 1 2008
End Date
April 1 2009
Last Update
April 13 2009
Active Locations (1)
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1
Hospital Clínico San Carlos
Madrid, Madrid, Spain, 28040