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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00750958
Other study ID # 807119
Secondary ID
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


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
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