Validation of the NTX Wireless Patient Monitoring System (TATRC)

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. Identifier: NCT00644644
Recruitment Status : Completed
First Posted : March 27, 2008
Last Update Posted : April 11, 2017
Information provided by (Responsible Party):
Dan France, Vanderbilt University

Brief 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

Condition or disease Intervention/treatment
Desaturation Bradycardia Tachycardia Hypertension Hypotension Other: Rapid Response Team (NTX wireless monitoring system)

Detailed 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

Study Type : Observational
Actual Enrollment : 1303 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : March 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Group/Cohort Intervention/treatment
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.
Other Name: - attending nurse action per VUMC protocol

Primary Outcome Measures :
  1. 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 [ Time Frame: 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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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Post-op orthopedic and GI patients who will be admitted for a minimum of 24 hours to the Round Wing area of Vanderbilt University Medical Center.

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

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 identifier (NCT number): NCT00644644

United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University Medical Center
Principal Investigator: Daniel J France, PhD, MPH Vanderbilt University Medical Center

Additional Information:
Responsible Party: Dan France, Associate Professor, Vanderbilt University Identifier: NCT00644644     History of Changes
Other Study ID Numbers: 061241
First Posted: March 27, 2008    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: April 2017

Keywords provided by Dan France, Vanderbilt University:
Nihon Kohden
mobile monitoring

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes