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

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.

Study Overview

• Status: Completed
• Conditions: Critically Ill Patients; Cardiovascular Surgery Telemetry Patients
• Intervention / Treatment: Other: Disposable ECG-LW

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
• Enrollment (Actual): 4056
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Covidien disposable ECG lead wires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood stream infection	culture findings	7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
false/nuisance alarms	alarms generated by ECG tracings due to various causes (leads off, leads crimped, etc)	4 months

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Nancy M Albert, PhD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: August 5, 2011
• First Submitted That Met QC Criteria: August 5, 2011
• First Posted (Estimate): August 8, 2011

Study Record Updates

• Last Update Posted (Estimate): February 23, 2016
• Last Update Submitted That Met QC Criteria: February 21, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Infection; ICU; Telemetry; ECG lead wire monitoring; Nuisance alarms
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: clevelandCF