Recruitment

Recruitment Status
Withdrawn

Inclusion Criterias

At least 25 % of the subjects should be hypertensive
Age ≥ 18 years old
At least 30% of the subjects must be males (n=29)
...
At least 25 % of the subjects should be hypertensive
Age ≥ 18 years old
At least 30% of the subjects must be males (n=29)
At least 5 % of the subjects should be hypotensive
Blood pressure distribution:
Limb size circumference ≥ 17 cm
At least 30% of the subjects must be female (n=29)

Exclusion Criterias

Premature ventricular contractions (PVC)
Metal screws
Acknowledged pregnancy
...
Premature ventricular contractions (PVC)
Metal screws
Acknowledged pregnancy
Breached skin
Pacemaker
Shoulder prosthesis
Presence of an arterial-venous shunt
Recent axillary node dissection
Sensitivity or allergy towards adhesives
Diagnosed cardiac arrhythmia (tachycardia, bradycardia, atrial/ventricular fibrillation)
Surgical clips
Bone plates
Premature arterial contractions (PAC)
Elbow prosthesis
Cardiac Resynchronization Therapy - Defibrillator (CRT-D)
Implantable Cardiac Defibrillator (ICD)
Metal chips

Summary

Conditions
  • Healthy
  • Hypertension
  • Hypotension
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 com...

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.

Inclusion Criterias

At least 25 % of the subjects should be hypertensive
Age ≥ 18 years old
At least 30% of the subjects must be males (n=29)
...
At least 25 % of the subjects should be hypertensive
Age ≥ 18 years old
At least 30% of the subjects must be males (n=29)
At least 5 % of the subjects should be hypotensive
Blood pressure distribution:
Limb size circumference ≥ 17 cm
At least 30% of the subjects must be female (n=29)

Exclusion Criterias

Premature ventricular contractions (PVC)
Metal screws
Acknowledged pregnancy
...
Premature ventricular contractions (PVC)
Metal screws
Acknowledged pregnancy
Breached skin
Pacemaker
Shoulder prosthesis
Presence of an arterial-venous shunt
Recent axillary node dissection
Sensitivity or allergy towards adhesives
Diagnosed cardiac arrhythmia (tachycardia, bradycardia, atrial/ventricular fibrillation)
Surgical clips
Bone plates
Premature arterial contractions (PAC)
Elbow prosthesis
Cardiac Resynchronization Therapy - Defibrillator (CRT-D)
Implantable Cardiac Defibrillator (ICD)
Metal chips

Tracking Information

NCT #
NCT01954446
Collaborators
Not Provided
Investigators
  • Principal Investigator: Michael H Olsen, Prof. MD Odense University Hospital
  • Michael H Olsen, Prof. MD Odense University Hospital