NCT00665886

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2008

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

April 13, 2009

Status Verified

April 1, 2009

Enrollment Period

3 months

First QC Date

April 22, 2008

Last Update Submit

April 10, 2009

Conditions

Catheterization, Peripheral

Keywords

Peripheral venous catheterCatheter-related complicationBacterial ColonizationDwell timeClosed systemCostsPolyurethaneTeflon

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (1)

  • 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.

Study Arms (2)

1

EXPERIMENTAL

Experimental Group (Closed System): Nexiva® Safety IV Catheter from BD (Becton Dickinson). The catheter has wings, a passive safety feature, an integrated Y extension tubing integrated and needle-less access using a split septum BD QSyte®. In order to completely close the Y connector a second Q-Syte® is added from the moment of catheter insertion

Device: Closed Intravenous System - Nexiva®

2

ACTIVE COMPARATOR

Control group (Open System): A 'mounted' system consisting of the Vasocan® Safety catheter of B. Braun Medical, SA. To the control catheters a three-way tap ('stopcock') with extension tubing 10 cm long (Connecta® Extra 3, from BD) is added. This comes as one unit (tap and tubing are integrated). When not in use the three-way tap ('stopcock') remains closed using a red cork Luer/Luer-Lock Sollner®, made by Amebil, SA.

Device: Open Intravenous System - Vasocan®

Interventions

Open Intravenous System - Vasocan®DEVICE

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.

Also known as: Vasocan® Safety catheter of B. Braun Medical, Connecta® Extra 3 of BD, Luer/Luer-Lock of Sollner®
2
Closed Intravenous System - Nexiva®DEVICE

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.

Also known as: Nexiva®, QSyte®.
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • Anticipated use of the catheter and/or stay in the unit of less than 24 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínico San Carlos

Madrid, Madrid, 28040, Spain

Location

Study Officials

  • Juan L Gonzalez Lopez, M.A. Nurse

    Hospital Clínico San Carlos (Madrid, Spain)

    STUDY CHAIR

  • Juan Luis González López, M.A. Nurse

    Hospital Clínico San Carlos (Madrid, Spain)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 22, 2008

First Posted

April 24, 2008

Study Start

March 1, 2008

Primary Completion

June 1, 2008

Study Completion

April 1, 2009

Last Updated

April 13, 2009

Record last verified: 2009-04

Locations

ES(1)