NTX Wireless Patient Monitoring System

Completed

• Conditions: Desaturation; Bradycardia; Tachycardia; Hypertension; Hypotension

• Registration Number: NCT00654693
• Lead Sponsor: Vanderbilt University

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 Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-04-03
• Study First Submitted QC: 2008-04-03
• Study First Posted: 2008-04-09
• Primary Completion: 2009-01
• Study Completion: 2009-06
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-06
• Last Update Posted: 2012-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of patient compliance with wearing device	24 hour minimum post op

Secondary Outcome Measures

Name	Time	Method
Determine accuracy of the NTX wireless monitoring system	duration of patient involvement
Determine false alarm rates	duration of patient involvement

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States