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Completed

NCT Number: NCT00654693

NTX Wireless Patient Monitoring System

* Determine the accuracy of the NTX wireless monitoring system alerts * Evaluate patient compliance with wearing device * Determine false alarm rates

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Key information

Conditions

Desaturation Arrhythmias, Cardiac Bradycardia Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Hypertension Hypotension Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rapid Response Team

Other

If the subject is experiencing a life threatening change in their vital signs, the Rapid Response Team will be initiated per VUMC protocol.

Other names: - attending nurse action per VUMC protocol

Primary outcomes

  1. Evaluation of patient compliance with wearing device

    Time frame: 24 hour minimum post op

Secondary outcomes

  1. Determine accuracy of the NTX wireless monitoring system

    Time frame: duration of patient involvement

  2. Determine false alarm rates

    Time frame: duration of patient involvement

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 9, 2008
Registry last updated
Sep 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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