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NCT00644644 Clinical Trial

Validation of the NTX Wireless Patient Monitoring System

Hypertension Clinical Trial

— TATRC  

Official title:
A Validation of the NTX Wireless Patient Monitoring System in Combination With Novel Computer Interface to Generate Proactive Medical Responses to Patient Specific Events

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00644644
Other study ID # 061241
Secondary ID
Status Completed
Phase N/A
First received March 19, 2008
Last updated April 7, 2017
Start date March 2008
Est. completion date January 2010

Study information
Verified date April 2017
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

- Reduction in time to detection of Clinically Significant events

- Reduction of time to Intervention during Clinically Significant events

- Reduction in the number of admissions to Intensive Care

Description:

1200 patients will have wireless monitors attached to their arm. They will be randomized to have their vital signs filtered through software that generates alerts, or software that does not generate alerts. Low and high limit alarms will be set according to published guidelines and adjusted at will by the response team. If appropriate the Vanderbilt University Medical Center Rapid Response team will be initiated per Institutional Policy

Recruitment information / eligibility
Status Completed
Enrollment 1303
Est. completion date January 2010
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Ability to give written informed consent

- Patients that are hospitalized for longer than 24 hours and are located on the 4th, 5th, or 6th floor of the Vanderbilt University Medical Center Round Wing

- Patients must be =18 years of age

Exclusion Criteria:

- ICU patients

- Female subjects who are pregnant

- Patients < 18 years of age

- Patients that have a contradiction for continuous Blood Pressure monitoring

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Rapid Response Team (NTX wireless monitoring system)
If the subject is experiencing a life threatening change in their vital signs, the Rapid Response Team will be initiated per VUMC protocol.

Locations
Country Name City State
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (1)
Lead Sponsor Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To determine if the NTX wireless monitoring system in combination with a novel computer interface will provide early detection of potentially life threatening changes in patient's vital signs an interim analysis will be performed after 400 patients have been placed on the study, again after 800 have been places on the study
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