A Novel Non-interfering Arterial Blood Pressure Monitoring Device

Not Applicable

Withdrawn

• Conditions: Hypotension; Hypertension; Healthy

• Registration Number: NCT01954446
• Lead Sponsor: Sense A/S

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.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-05-29
• Status Verified: 2013-09
• Study First Submitted QC: 2013-09-26
• Last Update Submitted: 2013-09-26
• Study First Posted: 2013-10-01
• Last Update Posted: 2013-10-01
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Accuracy of measurement	Up to 4 months	The reference measurements are compared with the measurements made by the investigational device

Secondary Outcome Measures

Name	Time	Method
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