NCT00654693

NTX Wireless Patient Monitoring System

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 26 (actual)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Desaturation
• Bradycardia
• Tachycardia
• Hypertension
• Hypotension

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-01-01
• Completion: 2009-06-01
• First posted: 2008-04-09
• Last updated: 2012-09-07

Locations

1 site across 1 country: United States