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

March 19, 2008
March 25, 2008
March 2008
February 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00644644 on ClinicalTrials.gov Archive Site
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Validation of the NTX Wireless Patient Monitoring System
A Validation of the NTX Wireless Patient Monitoring System in Combination With Novel Computer Interface to Generate Proactive Medical Responses to Patient Specific Events
  • 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

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

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.

  • Desaturation
  • Bradycardia
  • Tachycardia
  • Hypertension
  • Hypotension
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
  • 1
    monitored
    Intervention: Other: Rapid Response Team (NTX wireless monitoring system)
  • 2
    control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
1200
June 2009
February 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00644644
061241
Yes
Daniel J. France, PhD, MPH, Vanderbilt University Medical Center
Vanderbilt University
Not Provided
Principal Investigator: Daniel J France, PhD, MPH Vanderbilt University
Vanderbilt University
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP