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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00750958
First Posted: September 11, 2008
Last Update Posted: September 11, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Datascope Patient Monitoring
  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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 ]

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

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
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Responsible Party: Dr. Charles Pollack, Jr., Pennsylvania Hospital
ClinicalTrials.gov Identifier: NCT00750958     History of Changes
Other Study ID Numbers: 807119
First Submitted: September 10, 2008
First Posted: September 11, 2008
Last Update Posted: September 11, 2008
Last Verified: September 2008

Keywords provided by Datascope Patient Monitoring:
cardiac rhythm changes