Clinical trial NCT02570906: Performance Assessment of a Remote Patient Monitoring Device
Official title: A Performance Assessment of a Remote Patient Monitoring Device in Measuring Heart Rate, Respiration Rate, Posture, and Activity Level
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Physiologic Monitoring
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2015-10-07
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Volunteers, Adults 18 to 50 years old

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.


Eligibility criteria: 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

Primary outcomes:
measure: Heart rate accuracy
timeFrame: On the day of enrollment to completion of one-time study visit
measure: Heart rate precision
timeFrame: On the day of enrollment to completion of one-time study visit
measure: Respiratory rate accuracy
timeFrame: On the day of enrollment to completion of one-time study visit
measure: Respiratory rate precision
timeFrame: On the day of enrollment to completion of one-time study visit
measure: Activity
timeFrame: On the day of enrollment to completion of one-time study visit
measure: Body orientation (position)
timeFrame: On the day of enrollment to completion of one-time study visit
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: William Whang, MD
role: PRINCIPAL_INVESTIGATOR
References: