ECG Leadwires: Disposable Versus Cleaned, Reusable (ECG-LW)
Primary Purpose
Critically Ill Patients, Cardiovascular Surgery Telemetry Patients
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Disposable ECG-LW
Sponsored by
About this trial
This is an interventional prevention trial for Critically Ill Patients focused on measuring ICU, Telemetry, ECG lead wire monitoring, Infection, Nuisance alarms
Eligibility Criteria
Inclusion Criteria:
- Primary HO: patients treated in an ICU setting; Secondary HO: Patients treated in cardiac telemetry setting
Exclusion Criteria:
- None
Sites / Locations
- Cleveland Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Reusable ECG leadwires-ICU
Disposable ECG leadwires-ICU
Arm Description
Current ECG leadwires will be used
Disposable ECG-LW
Outcomes
Primary Outcome Measures
Blood stream infection
culture findings
Secondary Outcome Measures
false/nuisance alarms
alarms generated by ECG tracings due to various causes (leads off, leads crimped, etc)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01411553
Brief Title
ECG Leadwires: Disposable Versus Cleaned, Reusable
Acronym
ECG-LW
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 Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill Patients, Cardiovascular Surgery Telemetry Patients
Keywords
ICU, Telemetry, ECG lead wire monitoring, Infection, Nuisance alarms
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4056 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Reusable ECG leadwires-ICU
Arm Type
No Intervention
Arm Description
Current ECG leadwires will be used
Arm Title
Disposable ECG leadwires-ICU
Arm Type
Active Comparator
Arm Description
Disposable ECG-LW
Intervention Type
Other
Intervention Name(s)
Disposable ECG-LW
Other Intervention Name(s)
Covidien disposable ECG lead wires
Intervention Description
Disposable ECG leadwires used in ICU and telemetry monitoring; 5 lead sets for ICU and 6-lead sets for telemetry
Primary Outcome Measure Information:
Title
Blood stream infection
Description
culture findings
Time Frame
7 months
Secondary Outcome Measure Information:
Title
false/nuisance alarms
Description
alarms generated by ECG tracings due to various causes (leads off, leads crimped, etc)
Time Frame
4 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary HO: patients treated in an ICU setting; Secondary HO: Patients treated in cardiac telemetry setting
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy M Albert, PhD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Learn more about this trial
ECG Leadwires: Disposable Versus Cleaned, Reusable
We'll reach out to this number within 24 hrs