Catheterization, Peripheral Clinical Trial
— COSMOSOfficial title:
Randomized Study of Closed Peripheral Intravenous Systems Versus Mounted Open Systems
Verified date | April 2009 |
Source | Hospital San Carlos, Madrid |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Ministry of Health |
Study type | Interventional |
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 handling and effectiveness (as defined by time of survival without complications), security provided to professionals and patients against accidental blood exposure or needlestick injury, catheter-related complications such as phlebitis, pain and blockage and overall costs of the two systems.
Status | Completed |
Enrollment | 1200 |
Est. completion date | April 2009 |
Est. primary completion date | June 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Clínico San Carlos | Madrid |
Lead Sponsor | Collaborator |
---|---|
Hospital San Carlos, Madrid | Foundation for Biomedical Research and Innovation |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Length of time catheter remains in place without clinical symptoms | For the individual patient: Dwell time of the catheter free of complications, defined as the average time in hours from the insertion to the withdrawal of the catheter. For the study itself: From March through June, 2008. | Yes | |
Secondary | Incidence of complications of the catheter, bacterial colonization of catheter tips and costs of therapy. | For an individual patient: From the randomized insertion of the catheter until its withdrawal. For the study itself: From March through June, 2008. | Yes |
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