Validation of the NTX Wireless Patient Monitoring System

NCT ID: NCT00644644

Last Updated: 2017-04-11

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

1303 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-31

Study Completion Date

2010-01-31

Brief Summary

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* 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

Detailed Description

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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

Conditions

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Desaturation Bradycardia Tachycardia Hypertension Hypotension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

monitored

Rapid Response Team (NTX wireless monitoring system)

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.

2

control

No interventions assigned to this group

Interventions

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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.

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 Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Dan France

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel J France, PhD, MPH

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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061241

Identifier Type: -

Identifier Source: org_study_id

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