NTX Wireless Patient Monitoring System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
James Berry, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00654693
First received: April 3, 2008
Last updated: September 6, 2012
Last verified: September 2012
  Purpose
  • Determine the accuracy of the NTX wireless monitoring system alerts
  • Evaluate patient compliance with wearing device
  • Determine false alarm rates

Condition Intervention
Desaturation
Bradycardia
Tachycardia
Hypertension
Hypotension
Other: Rapid Response Team

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot Study to Evaluate the Performance of Nihon Kohden's NTX Wireless Patient Monitoring System

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Evaluation of patient compliance with wearing device [ Time Frame: 24 hour minimum post op ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine accuracy of the NTX wireless monitoring system [ Time Frame: duration of patient involvement ] [ Designated as safety issue: No ]
  • Determine false alarm rates [ Time Frame: duration of patient involvement ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: March 2008
Study Completion Date: June 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
monitored
patients hospitalized for longer than 24 hours and are located on the 4th, 5th, and 6th floors of the Vanderbilt University Medical Center Round Wing
Other: Rapid Response Team
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

Detailed Description:

Approximately 150 patients will have wireless monitors attached to their arm. They will have their vital signs filtered through software that generates alerts and records data. The alert engine will produce pager and application based pop-up alerts which will be sent to the research nurse. Low and high limit alarms will be set according to the published guidelines (Hillman, K. et. Al., Resuscitation 48(2): 105-10, 2001) and adjusted at will by the response team.

During this portion of the study, the following research related procedures will be performed:

  • begin continuous vital signs monitoring (BP - 1x per hour, 3 lead ECG -continuous, HR - continuous, SpO2 - continuous)
  • PI or Co-PI will review each alert that's generated. The clinical significance will be determined and recorded in the study database
  • Record patient's signs and symptoms daily
  • Assess concomitant
  • Assess AE's, SAEs
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants will be recruited in the Vanderbilt University Medical Center pre-operative clinic or in the Round Wing, after the effects of anesthesia have worn off. Before performing any trial-related procedures, written Informed Consent and HIPAA authorization will be obtained.

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: NCT00654693

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: James M Berry, M.D. Vanderbilt University
  More Information

Additional Information:
No publications provided

Responsible Party: James Berry, Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00654693     History of Changes
Other Study ID Numbers: 080021
Study First Received: April 3, 2008
Last Updated: September 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
NTX
Nihon Kohden
mobile monitoring
monitoring
nihon
kohden
monitoring device
remote monitoring
wireless

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

ClinicalTrials.gov processed this record on April 22, 2014