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NTX Wireless Patient Monitoring System

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00654693
Enrollment
26
Registered
2008-04-09
Start date
2008-03-31
Completion date
2009-06-30
Last updated
2012-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bradycardia, Desaturation, Hypertension, Hypotension, Tachycardia

Keywords

NTX, Nihon Kohden, mobile monitoring, monitoring, nihon, kohden, monitoring device, remote monitoring, wireless

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

Interventions

OTHERRapid 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.

Sponsors

Vanderbilt University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Evaluation of patient compliance with wearing device24 hour minimum post op

Secondary

MeasureTime frame
Determine accuracy of the NTX wireless monitoring systemduration of patient involvement
Determine false alarm ratesduration of patient involvement

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026