Developing and Maintaining a Central Venous Catheter Registry

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Lehigh Valley Hospital
ClinicalTrials.gov Identifier:
NCT01165411
First received: July 12, 2010
Last updated: August 2, 2010
Last verified: August 2010

July 12, 2010
August 2, 2010
August 2008
January 2015   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]

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.

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 ] [ Designated as safety issue: Yes ]

All data elements collected are either part of the standard of care during routine insertion of CVCs and 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.

Complete list of historical versions of study NCT01165411 on ClinicalTrials.gov Archive Site
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Developing and Maintaining a Central Venous Catheter Registry
Developing and Maintaining a Central Venous Catheter Registry

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.

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Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample

All patients that have CVCs and PICC lines placed at LVH

Central Line-associated Bloodstream Infection
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Patients with CVCs and PICC lines placed
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. Erratum in: N Engl J Med. 2007 Jun 21;356(25):2660.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
4530
January 2016
January 2015   (final data collection date for primary outcome measure)

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.
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01165411
Registry
No
Valerie Rupp, RN, BSN, Lehigh Valley Health Network
Lehigh Valley Hospital
Not Provided
Principal Investigator: Valerie A Rupp, RN, BSN Lehigh Valley Health Network
Lehigh Valley Hospital
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP