NTX Wireless Patient Monitoring System

September 6, 2012 updated by: James Berry, Vanderbilt University

A Pilot Study to Evaluate the Performance of Nihon Kohden's NTX Wireless Patient Monitoring System

  • Determine the accuracy of the NTX wireless monitoring system alerts
  • Evaluate patient compliance with wearing device
  • Determine false alarm rates

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • - attending nurse action per VUMC protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of patient compliance with wearing device
Time Frame: 24 hour minimum post op
24 hour minimum post op

Secondary Outcome Measures

Outcome Measure
Time Frame
Determine accuracy of the NTX wireless monitoring system
Time Frame: duration of patient involvement
duration of patient involvement
Determine false alarm rates
Time Frame: duration of patient involvement
duration of patient involvement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Investigators

  • Principal Investigator: James M Berry, M.D., Vanderbilt University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

April 3, 2008

First Submitted That Met QC Criteria

April 3, 2008

First Posted (Estimate)

April 9, 2008

Study Record Updates

Last Update Posted (Estimate)

September 7, 2012

Last Update Submitted That Met QC Criteria

September 6, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 080021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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