Performance Assessment of a Remote Patient Monitoring Device

Physiologic Monitoring Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02570906
• Other study ID #: COVMOPO0517
• Status: Completed
• Phase: N/A
• First received: September 1, 2015
• Last updated: February 25, 2016
• Start date: December 2015
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Other known NCT identifiers

• NCT02606968

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Physiologic Monitoring

Intervention

Device:
• Zephyr BioPatch
Remote patient monitoring devices: BioPatch™ (ZephyrLIFE Hospital System™)

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate accuracy	No follow-up visits will occur	On the day of enrollment to completion of one-time study visit	No
Primary	Heart rate precision	No follow-up visits will occur	On the day of enrollment to completion of one-time study visit	No
Primary	Respiratory rate accuracy	No follow-up visits will occur	On the day of enrollment to completion of one-time study visit	No
Primary	Respiratory rate precision	No follow-up visits will occur	On the day of enrollment to completion of one-time study visit	No
Primary	Activity	Activity will be classified as lying, upright, walking, or running.	On the day of enrollment to completion of one-time study visit	No
Primary	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	No