Validation of the NTX Wireless Patient Monitoring System

NCT00644644 | Completed DMC

• 1 other identifier: 061241
• Study Type: observational
• Target: 1,303
• Locations: 1 country
• Sites: 1

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

Conditions

Desaturation; Bradycardia; Tachycardia; Hypertension; Hypotension

Keywords

NTX; Nihon Kohden; mobile monitoring

Outcome Measures

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

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

Study Arms (2)

1

monitored

Other: Rapid Response Team (NTX wireless monitoring system)

2

control

Interventions

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.

Also known as: - attending nurse action per VUMC protocol

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Post-op orthopedic and GI patients who will be admitted for a minimum of 24 hours to the Round Wing area of Vanderbilt University Medical Center.

You may qualify if:

• 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

You may not qualify if:

• ICU patients
• Female subjects who are pregnant
• Patients \< 18 years of age
• Patients that have a contradiction for continuous Blood Pressure monitoring

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Related Links

• Vanderbilt University Medical Center Department of Anesthesiology

MeSH Terms

Conditions

Bradycardia; Tachycardia; Hypertension; Hypotension

Interventions

Hospital Rapid Response Team

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiac Conduction System Disease; Vascular Diseases

Intervention Hierarchy (Ancestors)

Patient Care Team; Patient Care Management; Health Services Administration

Study Officials

• Daniel J France, PhD, MPH

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 19, 2008
• First Posted: March 27, 2008
• Study Start: March 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: April 11, 2017

Record last verified: 2017-04

Locations

US (1)