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A Novel Non-interfering Arterial Blood Pressure Monitoring Device

NCT ID: NCT01954446

Last Updated: 2013-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2013-12-31

Brief Summary

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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

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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.

Conditions

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Hypertension Hypotension Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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ContiPress vs. 3M

ContiPress vs. 3M passive and during exercise

Group Type EXPERIMENTAL

3M

Intervention Type DEVICE

Conventional measuring of BP

ContiPressTM

Intervention Type DEVICE

New way of measuring BP - ContiPressTM

Investigational device

ContiPress vs. Mobil-O-Graph

ContiPress vs. Mobil-O-Graph passive, then oscillometric passive, then oscillometric for 24 hrs every 15 mins.

Group Type EXPERIMENTAL

3M

Intervention Type DEVICE

Conventional measuring of BP

ContiPressTM

Intervention Type DEVICE

New way of measuring BP - ContiPressTM

Investigational device

Mobil-O-Graph

Intervention Type DEVICE

2 different devices for oscillometric measurement of BP

Interventions

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3M

Conventional measuring of BP

Intervention Type DEVICE

ContiPressTM

New way of measuring BP - ContiPressTM

Investigational device

Intervention Type DEVICE

Mobil-O-Graph

2 different devices for oscillometric measurement of BP

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sense A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael H Olsen, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Other Identifiers

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DK011

Identifier Type: -

Identifier Source: org_study_id