Health Volunteer Validation Study
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERLocation
Sponsors
Zoll Medical Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory rate | Immediately | The difference between the μCor RR and the comparator RR will be lower than 2.8bpm (STD). |
| Posture | Immediately | 90% agreement between the positions (supine / reclined / upright) derived from μCor reporting and the known position |
| Activity | Immediately | μCor output is provided as active and not active. 90% correct classification of activity will be required of recordings. |
| Heart Rate | Immediately | — |
| ECG | Immediately | — |
Outcome results
None listed