Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT00654693
Status:
COMPLETED
Last Update Posted:
2012-09-07
First Post:
2008-04-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
NTX Wireless Patient Monitoring System
Sponsor:
Vanderbilt University
Organization:
Study Overview
Official Title:
A Pilot Study to Evaluate the Performance of Nihon Kohden's NTX Wireless Patient Monitoring System
Status:
COMPLETED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
* Determine the accuracy of the NTX wireless monitoring system alerts
* Evaluate patient compliance with wearing device
* Determine false alarm rates
* 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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: