Healthy, Hypertension, Hypotension
Conditions
Brief summary
The primary purpose of this investigation is to validate the performance and safety of the Investigational Device (ID) against a validated and legally cleared device for measuring Blood Pressure (BP). The secondary purpose is to validate the performance of the ID over a period of 24 hours against a validated and legally cleared device for Ambulatory Blood Pressure Monitoring (ABPM).
Detailed description
The clinical investigation is conducted as a controlled (subject as own control), prospective, randomised, comparative investigation in a population with a representative spread of BPs to ensure that the ID performs as good as current marketed and approved devices. The study will be conducted in compliance with the International Standard ANSI/AAMI/ISO 81060-2 - Non-invasive sphygmomanometers - Clinical validation of automated measurement type. This clinical investigation will enrol up to 96 male and female subjects to ensure the recording of 85/35 evaluable datasets in accordance with the ANSI/AAMI/ISO standard \[11\]. All measurements will be paired and falls into 2 categories: Auscultatory measurements as gold standard reference, oscillometric measurements for clinical practise reference and further validation of ambulatory monitoring and pulse shape measurements.
Interventions
DEVICE3M
Conventional measuring of BP
DEVICEContiPressTM
New way of measuring BP - ContiPressTM Investigational device
DEVICEMobil-O-Graph
2 different devices for oscillometric measurement of BP
Sponsors
Sense A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* At least 30% of the subjects must be males (n=29) * At least 30% of the subjects must be female (n=29) * Age ≥ 18 years old * Limb size circumference ≥ 17 cm * Blood pressure distribution: * At least 25 % of the subjects should be hypertensive * At least 5 % of the subjects should be hypotensive
Exclusion criteria
* Breached skin * Acknowledged pregnancy * Pacemaker * Diagnosed cardiac arrhythmia (tachycardia, bradycardia, atrial/ventricular fibrillation) * Implanted metal in upper limb: * Elbow prosthesis * Shoulder prosthesis * Metal screws * Bone plates * Metal chips * Surgical clips * Implantable Cardiac Defibrillator (ICD) * Cardiac Resynchronization Therapy - Defibrillator (CRT-D) * Premature ventricular contractions (PVC) * Premature arterial contractions (PAC) * Sensitivity or allergy towards adhesives * Presence of an arterial-venous shunt * Recent axillary node dissection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of measurement | Up to 4 months | The reference measurements are compared with the measurements made by the investigational device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin irritation | Up to 4 months | After removal of each investigational device the skin is assessed. Also participants are instructed to report any skin irritation to investigator |
Outcome results
None listed