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

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ClinicalTrials.gov Identifier: NCT01411553
Recruitment Status : Completed
First Posted : August 8, 2011
Last Update Posted : February 23, 2016
Sponsor:
Information provided by (Responsible Party):
Nancy M. Albert, Ph.D., The Cleveland Clinic

Brief Summary:
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 or disease Intervention/treatment Phase
Critically Ill Patients Cardiovascular Surgery Telemetry Patients Other: Disposable ECG-LW Not Applicable

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?

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4056 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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?
Study Start Date : September 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : February 2013

Arm Intervention/treatment
No Intervention: Reusable ECG leadwires-ICU
Current ECG leadwires will be used
Active Comparator: Disposable ECG leadwires-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




Primary Outcome Measures :
  1. Blood stream infection [ Time Frame: 7 months ]
    culture findings


Secondary Outcome Measures :
  1. false/nuisance alarms [ Time Frame: 4 months ]
    alarms generated by ECG tracings due to various causes (leads off, leads crimped, etc)



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: August 8, 2011    Key Record Dates
Last Update Posted: February 23, 2016
Last Verified: February 2016

Keywords provided by Nancy M. Albert, Ph.D., The Cleveland Clinic:
ICU
Telemetry
ECG lead wire monitoring
Infection
Nuisance alarms

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes