PREVENT - Prospective Rhythm Event Surveillance in the ER With NetGuard - Full Text View

Purpose

The purpose of this study is to determine the incidence of clinically significant rhythm and rate changes in ED patients who are not placed on conventional telemetry, and to test the user-friendliness of a automated clinician alter device in hectic and noisy setting of a busy emergency room.

Condition	Intervention
Cardiac Event	Procedure: NetGuard Automated Clinician Alert System

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Single Group Assignment, Efficacy Study

Official Title:	PREVENT - Prospective Rhythm Event Surveillance in the ER With NetGuard

Further study details as provided by Datascope Patient Monitoring:

Primary Outcome Measures:

Incidence of clinically significant rhythm and rate changes in ED patients. [ Time Frame: Patient ED stay ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Measure of user-friendliness of the device. [ Time Frame: Patient ED stay ] [ Designated as safety issue: No ]

Enrollment:	287
Study Start Date:	June 2008
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention ED patients that are not monitored with conventional therapy.	Procedure: NetGuard Automated Clinician Alert System Monitoring System for in-hospital patients who are typically unmonitored. Identifies and alarms for cardiac rhythm changes.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

> 18 yes
Agree to participate in study
Telemetry not indicated
Telemetry not available
Willingness to complete a questionnaire-

Exclusion Criteria:

Refusal to participate
Know sensitivity to adhesive
Language/communication barriers
Perceived high risk for lack of study compliance

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00750958

Locations


United States, Pennsylvania
	Dr Charles Pollack
	Philadelphia, Pennsylvania, United States, 19107
	University of Pennsylvania
	Philadelphia, Pennsylvania, United States, 19107

Sponsors and Collaborators

Datascope Patient Monitoring

Investigators


Principal Investigator:	Charles Pollack, MD	Pennslvania Hospital

More Information

Responsible Party:	Pennsylvania Hospital ( Dr. Charles Pollack, Jr. )
Study ID Numbers:	807119
First Received:	September 10, 2008
Last Updated:	September 10, 2008
ClinicalTrials.gov Identifier:	NCT00750958
Health Authority:	United States: Institutional Review Board

Keywords provided by Datascope Patient Monitoring:

cardiac rhythm changes

ClinicalTrials.gov processed this record on October 06, 2008

Sponsored by:	Datascope Patient Monitoring
Information provided by:	Datascope Patient Monitoring
ClinicalTrials.gov Identifier:	NCT00750958