NTX Wireless Patient Monitoring System

Study Overview
=================
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

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

Conditions
-----------------
Desaturation, Bradycardia, Tachycardia, Hypertension, Hypotension

Intervention / Treatment
-----------------
* Other: Rapid Response Team


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| monitored<br>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<br>* If the subject is experiencing a life threatening change in their vital signs, the Rapid Response Team will be initiated per VUMC protocol.<br>* Other names: - attending nurse action per VUMC protocol;|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NTX, Nihon Kohden, mobile monitoring, monitoring, nihon, kohden, monitoring device, remote monitoring, wireless