ECG Leadwires: Disposable Versus Cleaned, Reusable

Not Applicable

Completed

• Conditions: Critically Ill Patients; Cardiovascular Surgery Telemetry Patients
• Interventions: Other: Disposable ECG-LW

• Registration Number: NCT01411553
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2011-08-05
• Study First Submitted QC: 2011-08-05
• Study First Posted: 2011-08-08
• Study Start: 2011-09
• Primary Completion: 2012-12
• Study Completion: 2013-02
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-21
• Last Update Posted: 2016-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4056

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Disposable ECG leadwires-ICU	Disposable ECG-LW	Disposable ECG-LW

Primary Outcome Measures

Name	Time	Method
Blood stream infection	7 months	culture findings

Secondary Outcome Measures

Name	Time	Method
false/nuisance alarms	4 months	alarms generated by ECG tracings due to various causes (leads off, leads crimped, etc)

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States