Developing and Maintaining a Central Venous Catheter Registry

NCT ID: NCT01165411

Last Updated: 2016-10-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 4530 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2016-01-31

Brief Summary

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. The risk of central line associated bloodstream infections is typically expressed as the number of line infections per 1000 catheter days. This study's goal is to develop a uniform CL protocol, updated practice guidelines based on current evidence, and a standard procedural checklist based on CL care bundles recommended by the Institute for Healthcare Improvement. A secondary goal 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 that may be used as a valuable source of information for quality assurance, performance improvement, and research. 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.

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.

Conditions

Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients with CVCs and PICC lines placed

This group will have either Standard of Care (control) or Process Improvement infection control changes administered.

No interventions assigned to this group

Eligibility 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lehigh Valley Hospital

OTHER

Sponsor Role: lead

Responsible Party

Marna Rayl Greenberg

Director of EM Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Valerie A Rupp, RN, BSN

Role: PRINCIPAL_INVESTIGATOR

Lehigh Valley Health Network

Locations

Lehigh Valley Health Network

Allentown, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 10691590 (View on PubMed)

DerGurahian J. 5 million lives campaign hits midway point . . . but Institute for Healthcare Improvement officials say it's hard to judge progress. Mod Healthc. 2007 Dec 17;37(50):12-3. No abstract available.

Reference Type: BACKGROUND

PMID: 18203368 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17192537 (View on PubMed)

Other Identifiers

Registry

Identifier Type: -

Identifier Source: org_study_id