- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01165411
Developing and Maintaining a Central Venous Catheter Registry
Study Overview
Status
Conditions
Detailed Description
The use of central venous catheters(CVCs) has increased in both the inpatient and outpatient settings.CVCs disturb skin integrity and create vulnerability for bacterial and fungal infections. It has been estimated that 90% of bloodstream infections associated with catheters, are due to CVCs, and that 500 to 4,000 patients in the United States die annually due to these bloodstream infections (Mermel, 2000). The risk of central line (CL)associated bloodstream infections (CLAB) is typically expressed as the number of line infections per 1000 catheter days.A recent study demonstrated that following a set of standardized procedures can reduce the mean CLAB rate from 7.7 per 1000 catheter days to 1.4 (Pronovost et al., 2006).In an effort to decrease hospital acquired bloodstream infections and complications resulting from CVCs, an initiative to standardize and track CL placement throughout the institution is proposed. A uniform CL protocol will be developed;practice guidelines will be updated based on current evidence, and a standard procedural checklist will be developed based on CL care bundles recommended by the Institute for Healthcare Improvement (IHI)(5 Million Lives, 2007).Generally,a care bundle is a series of best practices that each enhances care when applied individually, but considerably improves care when implemented together.The CL care bundle includes hand hygiene, barrier precautions, chlorhexidine skin antisepsis, optimal site selection, and daily consideration of line necessity, with timely removal of unnecessary lines(5 Million Lives, 2007).Another goal of this initiative is to create a CL registry to capture and store data relevant to each CL placed throughout the institution.This registry will provide a wealth of data on CL insertions and complications which may be used as a valuable source of information for quality assurance, performance improvement, and research.Finally,with the knowledge and information obtained through this registry, educational offerings can be created, and a standardized institutional process for CL insertion can be developed.
Objective: 1.To capture information on each CL insertion throughout the institution.2.To capture and track the amount of days a patient has a CL in place.3.To capture and track CL infectious complications.4.To capture and track mechanical complications.5.To capture data,which may be used as a valuable source of information for quality assurance, performance improvement, education, and research.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Pennsylvania
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Allentown, Pennsylvania, United States, 18102
- Lehigh Valley Health Network
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients that have CVCs and PICC lines placed at LVH.
Exclusion Criteria:
- The patient has a CVC or PICC that was placed outside of LVHN.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Patients with CVCs and PICC lines placed
This group will have either Standard of Care (control) or Process Improvement infection control changes administered.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Track and store data on central line insertions and complications which may be used as a valuable source of information for quality assurance, performance improvement, and research
Time Frame: At time of complication or infection
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All data elements collected are either part of the standard of care during routine insertion of Central Venous Catheters (CVCs) and Peripheral Inserted Central Catheter (PICCs) or are undergoing process improvement so that they become the standard of care for these lines. The hospital data warehouse will be automatically fed information from multiple existing databases that are maintained within different locations of the hospital. Once merged, data will be transferred into the Horizon Business Insight database for performance improvement, quality assurance, and research purposes. |
At time of complication or infection
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Valerie A Rupp, RN, BSN, Lehigh Valley Health Network
Publications and helpful links
General Publications
- Pronovost P, Needham D, Berenholtz S, Sinopoli D, Chu H, Cosgrove S, Sexton B, Hyzy R, Welsh R, Roth G, Bander J, Kepros J, Goeschel C. An intervention to decrease catheter-related bloodstream infections in the ICU. N Engl J Med. 2006 Dec 28;355(26):2725-32. doi: 10.1056/NEJMoa061115. Erratum In: N Engl J Med. 2007 Jun 21;356(25):2660.
- Mermel LA. Prevention of intravascular catheter-related infections. Ann Intern Med. 2000 Mar 7;132(5):391-402. doi: 10.7326/0003-4819-132-5-200003070-00009. Erratum In: Ann Intern Med 2000 Sep 5;133(5):395.
- Institute for Healthcare Improvement (2007). Five Million Lives Campaign.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Registry
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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