Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT00654693
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:
NCT00654693
Study Brief:
Protocol Section:
NCT00654693