IPICCS: Peripheral Venous Catheter Colonization Study

Sponsor
Linkoeping University (Other)
Overall Status
Completed
CT.gov ID
NCT03351725
Collaborator
(none)
337
1
18.6
18.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: peripheral venous catheter (PVC)

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 Design

Study Type:
Observational
Actual Enrollment :
337 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Incidence of Peripheral Intravenous Cannula Colonization in a Swedish County Hospital
Actual Study Start Date :
Jun 1, 2016
Actual Primary Completion Date :
Dec 20, 2017
Actual Study Completion Date :
Dec 20, 2017

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Positive culture [2-7 days]

    Swab from peripheral venous catheter (PVC) in situ on patient having had the PVC for 48 hours or more.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ryhov County Hospital Jönköping Småland Sweden 55305

Sponsors and Collaborators

  • Linkoeping University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Boel Andersson Gäre, Professor, Linkoeping University
ClinicalTrials.gov Identifier:
NCT03351725
Other Study ID Numbers:
  • 0709323371
First Posted:
Nov 24, 2017
Last Update Posted:
Mar 7, 2019
Last Verified:
Mar 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Boel Andersson Gäre, Professor, Linkoeping University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 7, 2019