PREVENT - Prospective Rhythm Event Surveillance in the ER With NetGuard
This study has been completed.
Sponsor:
Datascope Patient Monitoring
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
| Tracking Information | |||||
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| First Received Date ICMJE | September 10, 2008 | ||||
| Last Updated Date | September 10, 2008 | ||||
| Start Date ICMJE | June 2008 | ||||
| Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Incidence of clinically significant rhythm and rate changes in ED patients. [ Time Frame: Patient ED stay ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Measure of user-friendliness of the device. [ Time Frame: Patient ED stay ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | PREVENT - Prospective Rhythm Event Surveillance in the ER With NetGuard | ||||
| Official Title ICMJE | PREVENT - Prospective Rhythm Event Surveillance in the ER With NetGuard | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE | Cardiac Event | ||||
| Intervention ICMJE | 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 |
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| Study Arm (s) | No Intervention: 1
ED patients that are not monitored with conventional therapy.
Intervention: Procedure: NetGuard Automated Clinician Alert System |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 287 | ||||
| Completion Date | July 2008 | ||||
| Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00750958 | ||||
| Other Study ID Numbers ICMJE | 807119 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Dr. Charles Pollack, Jr., Pennsylvania Hospital | ||||
| Study Sponsor ICMJE | Datascope Patient Monitoring | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Datascope Patient Monitoring | ||||
| Verification Date | September 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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