Performance Assessment of a Remote Patient Monitoring Device

A Performance Assessment of a Remote Patient Monitoring Device in Measuring Heart Rate, Respiration Rate, Posture, and Activity Level

This study will evaluate the performance of the Zephyr BioPatch in measuring heart rate, respiration rate, posture, and activity level compared to reference devices in healthy adult subjects during a variety of situations including hospital room movements, talking, and a short bout of exercise.

Study Overview

• Status: Completed
• Conditions: Physiologic Monitoring
• Intervention / Treatment: Device: Zephyr BioPatch

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy Volunteers, Adults 18 to 50 years old

Description

Inclusion Criteria:

1. Signed and dated informed consent by subject or legally authorized representative (LAR)
2. Male or female of any race
3. 18-50 years of age, inclusive
4. Willingness to have study devices attached during study participation
5. Willingness to participate in all aspects of the study
6. Ability to walk without human assistance or walking aides (e.g. cane or walker), in the opinion of the investigator

Exclusion Criteria:

1. Subject is unable to provide informed consent
2. Under 18 years of age or over 50 years of age
3. Implanted pacemaker or defibrillator
4. Diagnosis of atrial fibrillation as reported by the subject
5. Current hospital admission
6. History of hospital admission or a surgical procedure in the 60 days prior to study enrollment
7. Any contraindications to protocol specific repositioning techniques (e.g. turning on right side or left side or lying in supine position)
8. Female subject is pregnant and/or lactating as reported by the subject
9. Subject is considered as being morbidly obese (defined as BMI >39.5)
10. Subject is on any medications, in the opinion of the investigator, that would impair heart response during the short bout of exercise
11. A serious concurrent medical or other condition, in the opinion of the investigator, that would impair protocol compliance or safety of the subject

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate accuracy	No follow-up visits will occur	On the day of enrollment to completion of one-time study visit
Heart rate precision	No follow-up visits will occur	On the day of enrollment to completion of one-time study visit
Respiratory rate accuracy	No follow-up visits will occur	On the day of enrollment to completion of one-time study visit
Respiratory rate precision	No follow-up visits will occur	On the day of enrollment to completion of one-time study visit
Activity	Activity will be classified as lying, upright, walking, or running.	On the day of enrollment to completion of one-time study visit
Body orientation (position)	Body orientation (position) if lying horizontally will be classified as facing right, facing left, facing down (prone), or facing up (supine).	On the day of enrollment to completion of one-time study visit

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Principal Investigator: William Whang, MD, Columbia University

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: September 1, 2015
• First Submitted That Met QC Criteria: October 5, 2015
• First Posted (Estimate): October 7, 2015

Study Record Updates

• Last Update Posted (Estimate): February 26, 2016
• Last Update Submitted That Met QC Criteria: February 25, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: COVMOPO0517