Peripheral Venous Catheter Colonization Study (IPICCS)

March 6, 2019 updated by: Boel Andersson Gäre, Linkoeping University

Incidence of Peripheral Intravenous Cannula Colonization in a Swedish County Hospital

Peripheral intravenous cannulas (PIVCs) are utilized in large scale in modern health care. Known complications due to a PIVC are phlebitis, thrombosis, bleeding, nerve damage and infection. PIVC-related infection causes morbidity, mortality and increased healthcare costs. PIVC-related infections can and should be prevented.

Indwell time is a known risk factor for PIVC-related infection. Another factor potentially influencing the risk of developing PIVC-related infection is what type of PIVC that is being used. Roughly there are two types of PIVCs. One with an open injection valve and another with a closed injection valve. The former being far more used in our hospital and the latter being suggested as lowering the risk of PIVC-related infection compared to the open one.

The investigators aim with this study is to evaluate the incidence of PIVC-colonization in 300 patients at our 500-bed secondary level hospital in Sweden, as a first step in trying to understand what healthcare-providers can improve regarding prevention of PIVC-related infections.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background:

Peripheral intravenous cannulas (PIVCs) are utilized in large scale in modern health care. Known complications due to a PIVC are phlebitis, thrombosis, bleeding, nerve damage and infection. PIVC-related infection causes morbidity, mortality and increased healthcare costs. In an Australian study the investigators found the presence of a PIVC the most frequent cause (36%) of healthcare-associated Staphylococcus aureus bacteraemia during 2012. PIVC-related infections can and should be prevented.

Indwell time is a known risk factor for PIVC-related infection. Another factor potentially influencing the risk of developing PIVC-related infection is what type of PIVC that is being used. Roughly there are two types of PIVCs. One with an open injection valve and another with a closed injection valve. The former being far more used in Ryhov County Hospital, Sweden, and the latter being suggested as lowering the risk of PIVC-related infection compared to the open one.

In a systematic review from 2006 Maki et al report a point incidence of blood stream infections of 0,5 per 1000 catheter-days in PIVCs. In 2014 Hammarskjöld reported an incidence of 0,6 per 1000 catheter-days regarding central venous catheters (CVC). Maki et al concludes "…, infection control programs must strive to consistently apply essential control measures and preventive technologies with all types of intravascular devices." The investigators find there is a gap between the large scale utilization of PIVCs and the knowledge about PIVC-related infections and recommendations on how to prevent them. Hammarskjöld et al has done research on infections related to CVCs, subcutaneous venous ports and on arterial cannulas but not PIVCs.

The aim with this study is to evaluate the incidence of PIVC-colonization at Ryhov County Hospital, a 500-bed secondary level hospital in Sweden, as a first step in trying to understand what can be done to improve work regarding prevention of PIVC-related infections.

Materials and methods

Setting The hospital is a 500-bed general county hospital including most medical, oncological and surgical specialties except neurosurgery and cardiac surgery. No solid organ or stem cell transplantations are performed.

Patients Patients admitted to surgical, medical or infectious wards were regularly included by a specifically trained nurse from June 2016 until December 2017.

Inclusion criteria: Patients ≥ 18 years of age with a PIVC in situ for 48 hours or more informed verbally and in written and invited to take part in the study. Exclusion criteria: Patients < 18 years of age.

Microbiological methods Intraluminal hub culturing from the two injection sites of the PIVC performed with sterile cotton-tipped applicators moistened with sterile sodium chloride 0,9 %. Swabs transported in Amies medium with charcoal. Identification performed by standard methods at our local microbiology laboratory (www.srga.org.accessed _ http:// www.srga.org.accessed/ _ January 1, 2007).

Statistics Descriptive. How many positive cultures and which type of microbes were found.

Study Type

Observational

Enrollment (Actual)

337

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

  • Sweden
    • Småland
      • Jönköping, Småland, Sweden, 55305
        • Ryhov County 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

Sampling Method

Non-Probability Sample

Study Population

Setting The hospital is a 500-bed general county hospital including most medical, oncological and surgical specialties except neurosurgery and cardiac surgery. No solid organ or stem cell transplantations are performed. Patients Patients admitted to surgical, medical or infectious wards were regularly included by a specifically trained nurse from June 2016 until December 2017.

Description

Inclusion Criteria:

  • 18 years or older hospitalized in Ryhov County Hosptial, Sweden, with perhiperal venous catheter in situ for 48 hours or more.

Exclusion Criteria:

  • Under 18 years of age.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Peripheral venous catheter indwell time more than 48 hours
Device: peripheral venous catheter (PVC)
No intervention is made only in situ swab from the PVC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive culture
Time Frame: 2-7 days
Swab from peripheral venous catheter (PVC) in situ on patient having had the PVC for 48 hours or more.
2-7 days

Collaborators and Investigators

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

Sponsor

Linkoeping University

Investigators

  • Principal Investigator: Boel Andersson Gäre, Professor, Linkoeping University, Sweden

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 (Actual)

June 1, 2016

Primary Completion (Actual)

December 20, 2017

Study Completion (Actual)

December 20, 2017

Study Registration Dates

First Submitted

November 15, 2017

First Submitted That Met QC Criteria

November 21, 2017

First Posted (Actual)

November 24, 2017

Study Record Updates

Last Update Posted (Actual)

March 7, 2019

Last Update Submitted That Met QC Criteria

March 6, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0709323371

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No individual data, but the the data regarding positive Cultures and what type of microbia found will be official

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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