NTX Wireless Patient Monitoring System

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00654693
• Other study ID #: 080021
• Status: Completed
• Phase: N/A
• First received: April 3, 2008
• Last updated: September 6, 2012
• Start date: March 2008
• Est. completion date: June 2009

Study information

• Verified date: September 2012
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

• Determine the accuracy of the NTX wireless monitoring system alerts

• Evaluate patient compliance with wearing device

• Determine false alarm rates

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bradycardia
• Desaturation
• Hypertension
• Hypotension
• Tachycardia

Intervention

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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of patient compliance with wearing device		24 hour minimum post op	No
Secondary	Determine accuracy of the NTX wireless monitoring system		duration of patient involvement	No
Secondary	Determine false alarm rates		duration of patient involvement	No

External Links

•   Vanderbilt University Medical Center Department of Anesthesiology