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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
  Purpose

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.


Condition
Central Line-associated Bloodstream Infection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Developing and Maintaining a Central Venous Catheter Registry

Further study details as provided by Lehigh Valley Hospital:

Primary Outcome Measures:
  • 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.



Enrollment: 4530
Study Start Date: August 2008
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with CVCs and PICC lines placed

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients that have CVCs and PICC lines placed at LVH

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01165411

Locations
United States, Pennsylvania
Lehigh Valley Health Network
Allentown, Pennsylvania, United States, 18102
Sponsors and Collaborators
Lehigh Valley Hospital
Investigators
Principal Investigator: Valerie A Rupp, RN, BSN Lehigh Valley Health Network
  More Information

Publications:
Responsible Party: Valerie Rupp, RN, BSN, Lehigh Valley Health Network
ClinicalTrials.gov Identifier: NCT01165411     History of Changes
Other Study ID Numbers: Registry
Study First Received: July 12, 2010
Last Updated: August 2, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Lehigh Valley Hospital:
Central Catheterization
Central Line
Database
Registry
Registries

ClinicalTrials.gov processed this record on November 20, 2014