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OpenTrials
Completed

NCT Number: NCT02975050

Vital Signs Validation Study of the μ-Cor System (ViVUS Validation)

This study has the following objective:

• To validate the capability of the μ-Cor System to monitor ECG, Heart Rate (HR), Respiration Rate (RR), Posture and Activity in healthy human subjects.

The μ-Cor validation will be demonstrated at two body locations:

1. Side location (below left armpit) for study arm 1, and 2. Front location (upper left chest) for study arm 2 An FDA-cleared comparator device will be used to support the validation of the study device.

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Key information

Conditions

Health Volunteer Validation Study

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

This study has the following objective:

  • To validate the capability of the μ-Cor System to monitor ECG, Heart Rate (HR), Respiration Rate (RR), Posture and Activity in healthy human subjects.

The μ-Cor validation will be demonstrated at two body locations:

  • Side location (below left armpit) for study arm 1, and
  • Front location (upper left chest) for study arm 2 An FDA-cleared comparator device will be used to support the validation of the study device.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subject is at least 21 years of age or older.
  • Subject is willing and able to sign the Informed Consent Form.
  • Subject is healthy, able and willing to complete all the preparation steps and study procedures.

Exclusion criteria

  • Female subject with a known pregnancy or unsure about pregnancy status.
  • Subjects with allergies and/or skin sensitivities to electrode hydrogel and/or acrylic based adhesive.
  • Subjects with skin breakdown in areas where device placement is required.
  • Subjects with chronic lung disease or asthma.
  • Subjects with a history of cardiovascular diseases.
  • Subjects who are diabetic.
  • Subjects living with kidney failure or dialysis.
  • Subjects with a history of liver failure.
  • Subjects with any known malignancy (i.e. cancer patients).
  • Subjects with implanted devices in the thoracic region

Treatment and study plan

Location

Other

Primary outcomes

  1. Respiratory rate

    Time frame: Immediately

    The difference between the μCor RR and the comparator RR will be lower than 2.8bpm (STD).

  2. Posture

    Time frame: Immediately

    90% agreement between the positions (supine / reclined / upright) derived from μCor reporting and the known position

  3. Activity

    Time frame: Immediately

    μCor output is provided as "active" and "not active". 90% correct classification of activity will be required of recordings.

  4. Heart Rate

    Time frame: Immediately

  5. ECG

    Time frame: Immediately

Sponsors and collaborators

Lead sponsor

Zoll Medical Corporation

Industry

Registry information

Acronym: ViVUS

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 29, 2016
Registry last updated
Jul 7, 2020

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.