Performance Assessment of a Remote Patient Monitoring Device

Completed

• Conditions: Physiologic Monitoring

• Registration Number: NCT02570906
• Lead Sponsor: Medtronic - MITG

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-01
• Study First Submitted QC: 2015-10-05
• Study First Posted: 2015-10-07
• Study Start: 2015-12
• Primary Completion: 2016-01
• Status Verified: 2016-02
• Study Completion: 2016-02
• Last Update Submitted: 2016-02-25
• Last Update Posted: 2016-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States