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PREVENT - Prospective Rhythm Event Surveillance in the ER With NetGuard (PREVENT)

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ClinicalTrials.gov Identifier: NCT00750958
Recruitment Status : Completed
First Posted : September 11, 2008
Last Update Posted : September 11, 2008
Sponsor:
Information provided by:
Datascope Patient Monitoring

Brief 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.

Condition or disease Intervention/treatment Phase
Cardiac Event Procedure: NetGuard Automated Clinician Alert System Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 287 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: PREVENT - Prospective Rhythm Event Surveillance in the ER With NetGuard
Study Start Date : June 2008
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Arm Intervention/treatment
No Intervention: 1
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.
Other Name: NetGurard Automated Clinican Alert Systemm



Primary Outcome Measures :
  1. Incidence of clinically significant rhythm and rate changes in ED patients. [ Time Frame: Patient ED stay ]

Secondary Outcome Measures :
  1. Measure of user-friendliness of the device. [ Time Frame: Patient ED stay ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr. Charles Pollack, Jr., Pennsylvania Hospital
ClinicalTrials.gov Identifier: NCT00750958     History of Changes
Other Study ID Numbers: 807119
First Posted: September 11, 2008    Key Record Dates
Last Update Posted: September 11, 2008
Last Verified: September 2008

Keywords provided by Datascope Patient Monitoring:
cardiac rhythm changes