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

This study has been completed.
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: August 5, 2013
Last verified: August 2013
  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
Critically Ill Patients
Cardiovascular Surgery Telemetry Patients
Other: Disposable ECG-LW

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)


Enrollment: 4056
Study Start Date: September 2011
Study Completion Date: February 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Reusable ECG leadwires-ICU
Current ECG leadwires will be used
Placebo Comparator: Reusable Telemetry ECG leadwires
Usual care 6-lead ECG leadwire sets; reusable
Active Comparator: ECG LW- Disposable; ICU
Disposable ECG-LW
Other: Disposable ECG-LW
Disposable ECG leadwires used in ICU and telemetry monitoring; 5 lead sets for ICU and 6-lead sets for telemetry
Other Name: Covidien disposable ECG lead wires
Active Comparator: ECG-LW Disposable; 6 leads-Tele
Disposable ECG-LW
Other: Disposable ECG-LW
Disposable ECG leadwires used in ICU and telemetry monitoring; 5 lead sets for ICU and 6-lead sets for telemetry
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
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: NCT01411553

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Nancy M Albert, PhD 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: August 5, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014