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OpenTrials
Completed

NCT Number: NCT00644644

Validation of the NTX Wireless Patient Monitoring System

* Reduction in time to detection of Clinically Significant events * Reduction of time to Intervention during Clinically Significant events * Reduction in the number of admissions to Intensive Care

Completed

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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

1200 patients will have wireless monitors attached to their arm. They will be randomized to have their vital signs filtered through software that generates alerts, or software that does not generate alerts. Low and high limit alarms will be set according to published guidelines and adjusted at will by the response team. If appropriate the Vanderbilt University Medical Center Rapid Response team will be initiated per Institutional Policy

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 (NTX wireless monitoring system)

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. To determine if the NTX wireless monitoring system in combination with a novel computer interface will provide early detection of potentially life threatening changes in patient's vital signs

    Time frame: an interim analysis will be performed after 400 patients have been placed on the study, again after 800 have been places on the study

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

A Validation of the NTX Wireless Patient Monitoring System in Combination With Novel Computer Interface to Generate Proactive Medical Responses to Patient Specific Events

Acronym: TATRC

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Mar 27, 2008
Registry last updated
Apr 11, 2017

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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