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OpenTrials
Completed

NCT Number: NCT02570906

Performance Assessment of a Remote Patient Monitoring Device

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.

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Key information

Conditions

Physiologic Monitoring

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Columbia University Medical Center

New York, 10032, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Zephyr BioPatch

Device

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

Primary outcomes

  1. Heart rate accuracy

    Time frame: On the day of enrollment to completion of one-time study visit

    No follow-up visits will occur

  2. Heart rate precision

    Time frame: On the day of enrollment to completion of one-time study visit

    No follow-up visits will occur

  3. Respiratory rate accuracy

    Time frame: On the day of enrollment to completion of one-time study visit

    No follow-up visits will occur

  4. Respiratory rate precision

    Time frame: On the day of enrollment to completion of one-time study visit

    No follow-up visits will occur

  5. Activity

    Time frame: On the day of enrollment to completion of one-time study visit

    Activity will be classified as lying, upright, walking, or running.

  6. Body orientation (position)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 7, 2015
Registry last updated
Feb 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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