NTX Wireless Patient Monitoring System

NCT00654693 | Completed DMC

• 1 other identifier: 080021
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Desaturation; Bradycardia; Tachycardia; Hypertension; Hypotension

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Evaluation of patient compliance with wearing device

  24 hour minimum post op

Secondary Outcomes (2)

• Determine accuracy of the NTX wireless monitoring system

  duration of patient involvement

• Determine false alarm rates

  duration of patient involvement

Study Arms (1)

monitored

patients hospitalized for longer than 24 hours and are located on the 4th, 5th, and 6th floors of the Vanderbilt University Medical Center Round Wing

Other: Rapid Response Team

Interventions

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.

Also known as: - attending nurse action per VUMC protocol

monitored

Eligibility Criteria

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

Study Population

Participants will be recruited in the Vanderbilt University Medical Center pre-operative clinic or in the Round Wing, after the effects of anesthesia have worn off. Before performing any trial-related procedures, written Informed Consent and HIPAA authorization will be obtained.

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: 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

• James M Berry, M.D.

  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: Professor

Study Record Dates

• First Submitted: April 3, 2008
• First Posted: April 9, 2008
• Study Start: March 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: June 1, 2009
• Last Updated: September 7, 2012

Record last verified: 2012-09

Locations

US (1)