Non-returning Catheter Valve for Reducing CAUTI

October 17, 2013 updated by: Anupol Panitchote, Khon Kaen University

A Pilot Study of Non-returning Catheter Valve for Reducing Catheter-associated Urinary Tract Infection in Critically-ill Patients

This study was to determine efficacy of the non-returning catheter valve for reducing catheter associated urinary tract infection compared with conventional urine bag in critically ill patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Non-returning catheter valve (generic name) used UnometerTM SafetiTM Plus (trade name)

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Khon Kaen
      • Muang, Khon Kaen, Thailand, 40002
        • Srinagarind Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The participants who age more than 18 year and admitted to the medical intensive care unit or intermediate care unit
  • All participants must be retained the urinary catheter.

Exclusion Criteria:

  • The participants were diagnosed urinary tract infection before retention of the urinary catheter.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Non-returning catheter valve
Non-returning catheter valve (UnometerTM SafetiTM Plus) was used in experimental group only.
Device: Non-returning catheter valve
Other Names:
  • UnometerTM SafetiTM Plus
ACTIVE_COMPARATOR: Conventional urine bag
Conventional urine bag hasn't the non-returning catheter valve.
Device: Conventional urine bag

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence density of the catheter associated urinary tract infection (CAUTI)
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khon Kaen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (ACTUAL)

February 1, 2013

Study Completion (ACTUAL)

April 1, 2013

Study Registration Dates

First Submitted

October 11, 2013

First Submitted That Met QC Criteria

October 11, 2013

First Posted (ESTIMATE)

October 16, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

October 21, 2013

Last Update Submitted That Met QC Criteria

October 17, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAUTI-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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