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

History of Changes

Tracking Information

First Received Date ^ICMJE

April 3, 2008

Last Updated Date

September 6, 2012

Start Date ^ICMJE

March 2008

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00654693 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

NTX Wireless Patient Monitoring System

Official Title ^ICMJE

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

Brief Summary

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

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 ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

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.

Condition ^ICMJE

Desaturation
Bradycardia
Tachycardia
Hypertension
Hypotension

Intervention ^ICMJE

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

Study Group/Cohort (s)

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

Intervention: Other: Rapid Response Team

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2009

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00654693

Other Study ID Numbers ^ICMJE

080021

Has Data Monitoring Committee

Yes

Responsible Party

James Berry, Vanderbilt University

Study Sponsor ^ICMJE

Vanderbilt University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

James M Berry, M.D.

Vanderbilt University

Information Provided By

Vanderbilt University

Verification Date

September 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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