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Compact Closed System Versus Mounted Open System (COSMOS)

NCT00665886 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2009-04-13

No results posted yet for this study

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 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.

Conditions

  • Catheterization, Peripheral

Interventions

DEVICE

Open Intravenous System - Vasocan®

Vasocan® Safety catheter 18 G x 45 mm (Ref. 4248139S), 20 G x 33 mm (Ref. 4248112S) y 22 G x 25 mm (Ref. 4248090S)with wings and a passive safety mechanism. To the control catheters a three-way tap ('stopcock') with extension tubing 10 cm long (Connecta® Extra 3) from BD (ref 394995)will be added.

DEVICE

Closed Intravenous System - Nexiva®

BD Nexiva® Catheter (18G x 45 mm, 20 G x 32 mm, 22 G x 25 mm) (Ref. 383609,Ref. 383606,Ref. 383602) BD QSyte®, Ref. 385100 Catheter material is Vialon®. The entire system is Latex and PVC free.

Sponsors & Collaborators

  • Foundation for Biomedical Research and Innovation

    collaborator OTHER

  • Hospital San Carlos, Madrid

    lead OTHER

Principal Investigators

  • Juan L Gonzalez Lopez, M.A. Nurse · Hospital Clínico San Carlos (Madrid, Spain)

  • Juan Luis González López, M.A. Nurse · Hospital Clínico San Carlos (Madrid, Spain)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2008-06-30
Completion
2009-04-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00665886 on ClinicalTrials.gov