NTX Wireless Patient Monitoring System - Full Text View

Sponsored by:	Vanderbilt University
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00654693

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:	Cohort, Prospective
Official Title:	A Pilot Study to Evaluate the Performance of Nihon Kohden's NTX Wireless Patient Monitoring System

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: High Blood Pressure Low Blood Pressure

U.S. FDA Resources

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	150
Study Start Date:	March 2008
Estimated Study Completion Date:	June 2009
Estimated 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.

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:

Vanderbilt University Medical Center Department of Anesthesiology This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Vanderbilt University ( James M. Berry, M.D. )
Study ID Numbers:	080021
Study First Received:	April 3, 2008
Last Updated:	April 3, 2008
ClinicalTrials.gov Identifier:	NCT00654693 History of Changes
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

Study placed in the following topic categories:

Hypotension
Heart Diseases
Tachycardia
Bradycardia

Vascular Diseases
Arrhythmias, Cardiac
Hypertension

Additional relevant MeSH terms:

Hypotension
Pathologic Processes
Heart Diseases
Tachycardia
Bradycardia

Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Hypertension

ClinicalTrials.gov processed this record on September 09, 2009