ECG Leadwires: Disposable Versus Cleaned, Reusable

NCT ID: NCT01411553

Last Updated: 2016-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4056 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-02-28

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?

Conditions

Critically Ill Patients; Cardiovascular Surgery Telemetry Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Reusable ECG leadwires-ICU

Current ECG leadwires will be used

Group Type: NO_INTERVENTION

No interventions assigned to this group

Disposable ECG leadwires-ICU

Disposable ECG-LW

Group Type: ACTIVE_COMPARATOR

Disposable ECG-LW

Intervention Type: OTHER

Disposable ECG leadwires used in ICU and telemetry monitoring; 5 lead sets for ICU and 6-lead sets for telemetry

Interventions

Disposable ECG-LW

Disposable ECG leadwires used in ICU and telemetry monitoring; 5 lead sets for ICU and 6-lead sets for telemetry

Intervention Type: OTHER

Other Intervention Names

Covidien disposable ECG lead wires

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Nancy M. Albert, Ph.D.

Senior Director, Nursing Research and Innovation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nancy M Albert, PhD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

clevelandCF

Identifier Type: -

Identifier Source: org_study_id