NCT01411553

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,056

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 8, 2011

Completed
24 days until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

February 23, 2016

Status Verified

February 1, 2016

Enrollment Period

1.3 years

First QC Date

August 5, 2011

Last Update Submit

February 21, 2016

Conditions

Critically Ill PatientsCardiovascular Surgery Telemetry Patients

Keywords

ICUTelemetryECG lead wire monitoringInfectionNuisance alarms

Outcome Measures

Primary Outcomes (1)

  • Blood stream infection

    culture findings

    7 months

Secondary Outcomes (1)

  • false/nuisance alarms

    4 months

Study Arms (2)

Reusable ECG leadwires-ICU

NO INTERVENTION

Current ECG leadwires will be used

Disposable ECG leadwires-ICU

ACTIVE COMPARATOR

Disposable ECG-LW

Other: Disposable ECG-LW

Interventions

Disposable ECG-LWOTHER

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

Also known as: Covidien disposable ECG lead wires
Disposable ECG leadwires-ICU

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Infections

Study Officials

  • Nancy M Albert, PhD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Director, Nursing Research and Innovation

Study Record Dates

First Submitted

August 5, 2011

First Posted

August 8, 2011

Study Start

September 1, 2011

Primary Completion

December 1, 2012

Study Completion

February 1, 2013

Last Updated

February 23, 2016

Record last verified: 2016-02

Locations

US(1)