NTX Wireless Patient Monitoring System

NCT ID: NCT00654693

Last Updated: 2012-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-06-30

Brief Summary

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

Detailed Description

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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

Conditions

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Desaturation Bradycardia Tachycardia Hypertension Hypotension

Keywords

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NTX Nihon Kohden mobile monitoring monitoring nihon kohden monitoring device remote monitoring wireless

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Rapid Response Team

Intervention Type OTHER

If the subject is experiencing a life threatening change in their vital signs, the Rapid Response Team will be initiated per VUMC protocol.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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- attending nurse action per VUMC protocol

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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James Berry

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James M Berry, M.D.

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Related Links

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http://www.vandydreamteam.com

Vanderbilt University Medical Center Department of Anesthesiology

Other Identifiers

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080021

Identifier Type: -

Identifier Source: org_study_id