PREVENT - Prospective Rhythm Event Surveillance in the ER With NetGuard

Cardiac Event Clinical Trial

— PREVENT  

Official title:

PREVENT - Prospective Rhythm Event Surveillance in the ER With NetGuard

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00750958
• Other study ID #: 807119
• Status: Completed
• Phase: N/A
• First received: September 10, 2008
• Last updated: September 10, 2008
• Start date: June 2008
• Est. completion date: July 2008

Study information

• Verified date: September 2008
• Source: Datascope Patient Monitoring
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 287
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cardiac Event

Intervention

Procedure:
• NetGuard Automated Clinician Alert System
Monitoring System for in-hospital patients who are typically unmonitored. Identifies and alarms for cardiac rhythm changes.

Locations

Country	Name	City	State
United States	Dr Charles Pollack	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Datascope Patient Monitoring

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of clinically significant rhythm and rate changes in ED patients.		Patient ED stay	No
Secondary	Measure of user-friendliness of the device.		Patient ED stay	No