Validation of the NTX Wireless Patient Monitoring System

Completed

• Conditions: Bradycardia; Hypertension; Tachycardia; Desaturation; Hypotension
• Interventions: Other: Rapid Response Team (NTX wireless monitoring system)

• Registration Number: NCT00644644
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

* 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

Detailed Description

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

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-19
• Study First Submitted QC: 2008-03-25
• Study First Posted: 2008-03-27
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-07
• Last Update Posted: 2017-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1303

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

Arm && Interventions

Group	Intervention	Description
1	Rapid Response Team (NTX wireless monitoring system)	monitored

Primary Outcome Measures

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

Trial Locations

Locations (1)

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