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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05299060 -
Effectiveness of Cyanoacrylate Glue in the Fixation of Midline and Peripherally Inserted Central Catheters in Hospitalized Adult Patients: Randomised Clinical Trial (CIANO-ETI)
|
N/A | |
Terminated |
NCT00482742 -
Safety & Performance Randomized Study of the CiTop™ Guidewire for Peripheral CTO
|
N/A | |
Completed |
NCT00357799 -
VeinViewer for Peripheral IV Placement in Children With Difficult Intravenous (IV) Access
|
Phase 2/Phase 3 | |
Recruiting |
NCT03474978 -
Peripherally Inserted Central Catheter Insertion Site and Complication Rate in Neonates
|
N/A | |
Completed |
NCT03563703 -
Transfer of Technological Innovations to Nursing Practice: A Contribution to the Prevention of Infections
|
N/A | |
Completed |
NCT05265481 -
The Effect of Tapping in the Venous Dilatation for Peripheral IV Access
|
N/A | |
Active, not recruiting |
NCT02648334 -
Randomized Comparison of DCB for the Treatment of Superficial Femoral and Popliteal Peripheral Artery Disease
|
N/A | |
Completed |
NCT03148808 -
Natural Vascular Scaffold (NVS) Therapy
|
Phase 1 | |
Completed |
NCT04188262 -
Natural Vascular Scaffold (NVS) Therapy for Treatment of Atherosclerotic Lesions (Activate I)
|
Phase 1 | |
Completed |
NCT04085042 -
Impact of a Multimodal Intervention on Peripheral Venous Catheterization of Cancer Patients
|
N/A | |
Recruiting |
NCT04856826 -
Placement of Peripheral Venous Catheters Under Echo Guidance in a Post-emergency Medical Service
|
N/A | |
Terminated |
NCT01104103 -
Effectiveness Study of the BOA(R)-Constricting IV Band
|
N/A | |
Completed |
NCT02769442 -
Prospective, Randomized Controlled Comparison of TERUMO SurFlash Plus Versus BD Insyte Autoguard in an Urban ED
|
N/A | |
Completed |
NCT02795468 -
The Usefulness of Ultrasound Guided Technique Insertion of Radial Artery Catheter in Neonates and Infants
|
N/A | |
Recruiting |
NCT03592602 -
Evaluate the Impact of Arm Abduction and Adduction on the Intravascular Electrocardiograph During PICC Placement and the Tip Location Changes Related to it
|
N/A | |
Completed |
NCT04001764 -
Comparison of the Efficacy of Radial Artery Catheterization in Three Different Regions in Intensive Care Patients
|
N/A | |
Completed |
NCT03197246 -
Intravascular ECG During Insertion of Peripheral Inserted Central-venous Catheters: Replacement for Chest X-ray?
|
N/A | |
Terminated |
NCT05051020 -
Near-infrared Vein Imaging for Peripheral IV Placement
|
N/A | |
Terminated |
NCT04262947 -
Efficacy of Near-Infrared Vein Imaging for Difficult IV Placement
|
N/A | |
Completed |
NCT06033677 -
Increasing Security With End-zone Arterial Blood Pressure Monitoring During Surgery
|
N/A |