PREVENT - Prospective Rhythm Event Surveillance in the ER With NetGuard

NCT ID: NCT00750958

Last Updated: 2008-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

287 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2008-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiac Event

Keywords

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cardiac rhythm changes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

ED patients that are not monitored with conventional therapy.

Group Type NO_INTERVENTION

NetGuard Automated Clinician Alert System

Intervention Type PROCEDURE

Monitoring System for in-hospital patients who are typically unmonitored. Identifies and alarms for cardiac rhythm changes.

Interventions

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NetGuard Automated Clinician Alert System

Monitoring System for in-hospital patients who are typically unmonitored. Identifies and alarms for cardiac rhythm changes.

Intervention Type PROCEDURE

Other Intervention Names

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NetGurard Automated Clinican Alert Systemm

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Datascope Patient Monitoring

INDUSTRY

Sponsor Role lead

Responsible Party

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Pennsylvania Hospital

Principal Investigators

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Charles Pollack, MD

Role: PRINCIPAL_INVESTIGATOR

Pennslvania Hospital

Locations

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Dr Charles Pollack

Philadelphia, Pennsylvania, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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807119

Identifier Type: -

Identifier Source: org_study_id