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

August 5, 2011
August 5, 2013
September 2011
December 2012   (final data collection date for primary outcome measure)
Blood stream infection [ Time Frame: 7 months ] [ Designated as safety issue: No ]
culture findings
Same as current
Complete list of historical versions of study NCT01411553 on ClinicalTrials.gov Archive Site
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)
Same as current
Not Provided
Not Provided
 
ECG Leadwires: Disposable Versus Cleaned, Reusable
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?

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.

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?

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Critically Ill Patients
  • Cardiovascular Surgery Telemetry Patients
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
  • 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
    Intervention: Other: Disposable ECG-LW
  • Active Comparator: ECG-LW Disposable; 6 leads-Tele
    Disposable ECG-LW
    Intervention: Other: Disposable ECG-LW
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4056
February 2013
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01411553
clevelandCF
No
Nancy M. Albert, Ph.D., The Cleveland Clinic
The Cleveland Clinic
Not Provided
Principal Investigator: Nancy M Albert, PhD The Cleveland Clinic
The Cleveland Clinic
August 2013

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