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Validation of the NTX Wireless Patient Monitoring System (TATRC)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00644644
First received: March 19, 2008
Last updated: March 25, 2008
Last verified: March 2008
History of Changes
  Purpose
  • 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 Intervention
Desaturation
Bradycardia
Tachycardia
Hypertension
Hypotension
 Other: Rapid Response Team (NTX wireless monitoring system)

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1200
Study Start Date: March 2008
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
monitored
 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
2
control

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00644644

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

Additional Information:
Vanderbilt University Medical Center Department of Anesthesiology  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Daniel J. France, PhD, MPH, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00644644     History of Changes
Other Study ID Numbers: 061241
Study First Received: March 19, 2008
Last Updated: March 25, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
NTX
Nihon Kohden
mobile monitoring

Additional relevant MeSH terms:
Hypertension
Hypotension
Tachycardia
Bradycardia
Vascular Diseases
 Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 13, 2013