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ECG Leadwires: Disposable Versus Cleaned, Reusable (ECG LW)

This study is currently recruiting participants.
Verified March 2012 by The Cleveland Clinic
Sponsor:
Information provided by (Responsible Party):
Nancy M. Albert, Ph.D., The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01411553
First received: August 5, 2011
Last updated: March 30, 2012
Last verified: March 2012
History of Changes
  Purpose

Null hypothesis: (1) there is no difference in rates of ICU-acquired infection based on using disposable or cleaned, reusable ECG leadwires and (2) In cardiac surgical telemetry floors, there is no difference in false or nuisance sightings or crisis calls based on using disposable or cleaned, reusable ECG leadwires.


Condition Intervention
Intensive Care Patients
Cardiac Surgical Telemetry Patients
 Device: Disposable ECG leadwires; 5 and 6 lead sets
Other: No intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: ECG Leadwires: Do Disposable Leadwires Reduce the Incidence of Bacterial Infections in ICU Patients and Provide Adequate Signaling in Stepdown/Telemetry Environment Compared to Cleaned Reusable ECG Leadwires?

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Blood stream infection [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    culture findings


Secondary Outcome Measures:
  • false/nuisance alarms [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    alarms generated by ECG tracings due to various causes (leads off, leads crimped, etc)


Estimated Enrollment: 1000
Study Start Date: September 2011
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Reusable ECG leadwires-ICU
Current ECG leadwires will be used
 Other: No intervention
usual care
Experimental: Disposable ECG leadwires-ICU
Covidien disposable ECG leadwires
 Device: Disposable ECG leadwires; 5 and 6 lead sets
Disposable ECG leadwires used in ICU and telemetry monitoring
Other Name: Covidien disposable ECG lead wires
Active Comparator: Reusable Telemetry ECG leadwires
Usual care 6-lead ECG leadwire sets; reusable
 Other: No intervention
usual care
Experimental: Disposable Telemetry ECG leadwires
Covidien disposable ECG leadwires (6 lead)- Telemetry
 Device: Disposable ECG leadwires; 5 and 6 lead sets
Disposable ECG leadwires used in ICU and telemetry monitoring
Other Name: Covidien disposable ECG lead wires

Detailed Description:

Primary purposes: Using a randomized controlled trial methodology and randomizing similar (matched) intensive care units (ICU) to either disposable or cleaned, reusable ECG-LW: 1. Is there a difference in the rate of blood stream infection (BSI) and ventilator-associated pneumonia (VAP) in ICU environments (medical ICU, surgical ICU, cardiothoracic ICU, and neuroscience ICU) and surgical site infection (SSI); specifically, sternal wound infections in cardiothoracic ICU that utilize disposable vs. cleaned, reusable ECG-LW? 2. Is there a difference in ICU length of stay based on ECG-LW used: disposable vs. cleaned, reusable? 3. After controlling for patient age, comorbidity index and after removing patients who's date of BSI or VAP infections were within 48 hours of admission to the ICU, is there a difference in the rate of (A) blood stream infection (BSI), (B) ventilator-associated pneumonia (VAP) and (C) SSI in ICU environments (when applicable) that utilize disposable vs. cleaned, reusable ECG-LW? Secondary purposes: Using a randomized controlled trial methodology and randomizing similar telemetry units to either disposable or cleaned, reusable ECG-LW: 1. Is there a difference in the number of false/nuisance sightings/crisis calls (i.e., lead off, no telemetry, lead failure or other false alarms) identified by the Central Monitoring Unit (CMU)? 2. Is there a difference in true sightings/crisis calls identified by the CMU based on unit assignment of disposable or cleaned, reusable ECG-LW? 2b. If yes to #2, is there a difference in types of true sightings/calls identified by the CMUbased on assignment of disposable or cleaned, reusable ECG-LW?

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary HO: patients treated in an ICU setting; Secondary HO: Patients treated in cardiac telemetry setting

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01411553

Contacts
Contact: Nancy M Albert, PhD 216-444-7028 albertn@ccf.org
Contact: Jennifer Forney, BSN, RN 216-445-6462 forneyj@ccf.org

Locations
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Nancy M Albert, PhD     216-444-7028     albertn@ccf.org    
Principal Investigator: Nancy M Albert, PhD            
Sponsors and Collaborators
The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Nancy M. Albert, Ph.D., Senior Director, Nursing Research and Innovation, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01411553     History of Changes
Other Study ID Numbers: clevelandCF
Study First Received: August 5, 2011
Last Updated: March 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
ICU
Telemetry
ECG lead wire monitoring
Infection
Nuisance alarms

ClinicalTrials.gov processed this record on June 18, 2013