PREVENT - Prospective Rhythm Event Surveillance in the ER With NetGuard

This study has been completed.
Sponsor:
Information provided by:
Datascope Patient Monitoring
ClinicalTrials.gov Identifier:
NCT00750958
First received: September 10, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ 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
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

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
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, see Learn About Clinical Studies.

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

No publications provided

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

Keywords provided by Datascope Patient Monitoring:
cardiac rhythm changes

ClinicalTrials.gov processed this record on September 18, 2014