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Trial registered on ANZCTR


Registration number
ACTRN12617000774325
Ethics application status
Approved
Date submitted
23/05/2017
Date registered
26/05/2017
Date last updated
15/11/2019
Date data sharing statement initially provided
17/07/2019
Date results provided
17/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot testing of a new Blood Pressure measuring device on healthy adult volunteers
Scientific title
Phase 0 (pilot) testing of a new Blood Pressure measuring device on healthy adult volunteers at Cabrini Emergency Department, comparing the new skin contact device against gold standard devices; during rest, exercise and after administration of glyceryl trinitrate, to assess device performance for Blood Pressure measurement accuracy.
Secondary ID [1] 291851 0
nil
Universal Trial Number (UTN)
U1111-1196-2656
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
measurement of blood pressure 303104 0
Condition category
Condition code
Cardiovascular 302565 302565 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a device that utilises new technology to measure blood pressure non-invasively and cufflessly using a methodology called Pulse Transit Time (PTT). Simple electrodes and a radar device are placed on the skin between two points of an artery (in this case, the aorta in the chest). The blood pressure is deducted from the resultant delay of the electrical and mechanical impulse created by the blood moving along the artery between the two points.

The device consists of:

(i) Electrodes and leads:
*An electrode placed on each shoulder (similar to currently used ECG dots)
*A chest electrode (the radar) placed in the middle of the sternum
*A lead connecting the electrodes to the central processing unit
(ii) Central processing unit (CPU)
*A box that generates the radar signal out to the chest electrodes and receives the signals from the shoulder electrodes
(iii) Laptop computer
*Used to input the patient’s demographic data, non invasive arm cuff BP readings, visualise data obtained from the CPU, and host the algorithms used to deduct BP

To test this device, the following procedures will be followed:

Healthy adult volunteers will be enrolled.

A minimum of 29 participants will undergo static and blood pressure raising protocol. These participants will undertake the following:

Steps and manoeuvres
1 Measure lying BP
2 Change to sitting measure sitting BP
3 Handgrip both arms till failure, measure handgrip BP
4 Change to standing position, measure standing BP
5 Move to bike, Cycle for 2 min at 10-22 km/h or light effort
Measure BP after light exercise (brief rest following this whilst BPs are measured only)
6 Cycle for 2 min at 22-30 km/h or Medium effort
Measure BP after medium exercise (brief rest following this whilst BPs are measured only)
7 Cycle for 2 min at 30-40 km/h or Maximal effort
Measure BP after heavy exercise (rest following this, see below)
8 Rest at sitting position for 5 min
Measure sitting BP after 5 minutes rest

A minimum of 16 further participants will undergo a static and Blood Pressure lowering protocol:

First they will be screened for medical contraindications and consented for the utilisation of glyceryl trinitrate (GTN) medication. If able to proceed, the protocol will be as follows:

Participants rest supine for 10 minutes, then they would have 300 micrograms of GTN administered sublingually (under the tongue) and possibly another 300mcg 10 minutes later. BPs would be measured before and after the medication administration. The second dose will be given if the participant remains well and the BP has been lowered at first post GTN dose by less than 15mmHg. (minimum of 50% of BP lowering measurements have to be in the range of - 16 to - 30mmHg from baseline reading, the remaining lowered BP readings have to be between -15 to -1mmHg from baseline). BPs will be measured 3 minutely from the first dose of GTN onwards for 30 minutes total.

For all measurements of blood pressure by the new device, there will be a simultaneous measurement of the blood pressure by the gold standard control device. Blood pressures will be measured by a researcher who has been trained to take Blood Pressures accurately. This may be a research assistant with a science background, an engineer or a medical practitioner (Emergency Physician).

The approximate duration of each session for each participant in either group will be approximately an hour.

Training for researchers in how to measure Blood Pressures will meet or exceed the standards described in the International engineering protocol.
Intervention code [1] 297960 0
Diagnosis / Prognosis
Comparator / control treatment
Digital, oscillometric, arm-cuffed sphygmomanometer, (or similar gold-standard device as determined by international engineering standards) calibrated and tested for accuracy according to engineering standards prior to utilisation.

As in the device testing protocol above, the same researchers will measure the control BP readings, with the training described above. (as per international standard engineering protocol)
Control group
Active

Outcomes
Primary outcome [1] 301981 0
Testing for precision (mean absolute difference accuracy level) against engineering standards for new devices, compared to gold standard (arm-cuffed sphygmomanometer) to determine if the new device would be likely to meet those standards.
(International engineering standard IEEE 1708 for BP measurement)

Precision testing accuracy is undertaken by following the engineering standard IEEE 1708 for BP measurement and then comparing against "Table 3 - MAD accuracy level with comparison to the ANSI/AAMI SP10 and BHS evaluation systems"
This grades accuracy of readings into a recommended grading of A through to D. We aim to measure against Grade A which is a pass according to the standards.

Readings are compared to a gold standard device; which is determined by the engineering standards (e.g. Digital, oscillometric, arm-cuffed sphygmomanometer) or other device meeting the same gold-standard requirements as determined b the engineering standard.
Timepoint [1] 301981 0
December 2017, assessed at sequential testing sessions (5-10 participants per session) until the complete sample size is enrolled.
Secondary outcome [1] 334434 0
Determination of the best electrode placement location on the chest. Several electrodes will be placed across the chest wall. The most accurate will be determined by comparing against the gold standard readings. The most accurate location will inform future electrode lead placement.

Gold standard readings are assessed compared to a simultaneous digital, oscillometric, arm-cuffed sphygmomanometer (or other device meeting the same gold-standard requirements as determined b the engineering standard).
Timepoint [1] 334434 0
December 2017, assessed at sequential testing sessions (5-10 participants per session) until the complete sample size is enrolled.

Eligibility
Key inclusion criteria
Adult volunteers (age 18 and over)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion from any participation
Inability to undergo informed consent (e.g. speak or read English, reliably process information to make an informed decision)
Inability to undertake mild to moderate aerobic exercise (ride an exercise bike for 5 minutes)
Inability to undertake mild to moderate isotonic exercise (clenched hand grips)
Allergy to medical grade skin adhesive tapes
History of mastectomy with axillary node clearance, preventing the use of arm Blood Pressure measurement devices

Exclusion from the glyceryl trinitrate arm of the study
Unwillingness to divulge past medical history to a research medical practitioner
Past medical history of ischaemic heart disease (heart attack)
Past medical history of cerebrovascular disease (stroke)
Hypersensitivity to glyceryl trinitrate
Systolic blood pressure less than 100 mmHg
Pulse rate <50 or >150
Phosphodiesterase type 5 inhibitor use (sildenafil, vardenafil) within the last 4 days
Allergy to medical grade skin adhesive tapes
History of mastectomy with axillary node clearance, preventing the use of arm Blood Pressure measurement devices

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not randomised
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Participants act as their own controls, readings are taken simultaneously from the test and control device
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We will measure the device performance against international engineering standard IEEE 1708 for BP measurement; which defines the analysis standards and statistical methodology

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2017
Actual
1/10/2017
Date of last participant enrolment
Anticipated
30/09/2017
Actual
30/10/2017
Date of last data collection
Anticipated
30/09/2017
Actual
30/11/2017
Sample size
Target
45
Accrual to date
Final
43
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 7928 0
Cabrini Hospital - Malvern - Malvern
Recruitment postcode(s) [1] 15888 0
3144 - Malvern

Funding & Sponsors
Funding source category [1] 296348 0
University
Name [1] 296348 0
Monash University
Country [1] 296348 0
Australia
Funding source category [2] 296349 0
Hospital
Name [2] 296349 0
Cabrini Hospital
Country [2] 296349 0
Australia
Funding source category [3] 296350 0
Government body
Name [3] 296350 0
Victorian Government future industries fund
Country [3] 296350 0
Australia
Funding source category [4] 296351 0
Commercial sector/Industry
Name [4] 296351 0
Planet Innovation
Country [4] 296351 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Department of Electrical and Computer Systems Engineering
Building 72
Room:229
14 Alliance Lane
Monash University
Clayton
Victoria
3168
Country
Australia
Secondary sponsor category [1] 295280 0
Commercial sector/Industry
Name [1] 295280 0
Planet Innovation
Address [1] 295280 0
436 Edgar Rd
Box Hill
Vic
3128
Country [1] 295280 0
Australia
Secondary sponsor category [2] 295281 0
Charities/Societies/Foundations
Name [2] 295281 0
Cabrini Institute
Address [2] 295281 0
154 Wattletree Rd
Malvern
VIC
3144
Country [2] 295281 0
Australia
Secondary sponsor category [3] 295282 0
Individual
Name [3] 295282 0
A/Prof Keith Joe
Address [3] 295282 0
Emergency Department
Cabrini
183 Wattletree Rd
Malvern
Vic
3144
Country [3] 295282 0
Australia
Other collaborator category [1] 279554 0
Individual
Name [1] 279554 0
Dr Katherine Walker
Address [1] 279554 0
Emergency Department
Cabrini
183 Wattletree Rd
Malvern
Vic
3144
Country [1] 279554 0
Australia
Other collaborator category [2] 279555 0
Individual
Name [2] 279555 0
Mr William Dunlop
Address [2] 279555 0
Emergency Department
Cabrini
183 Wattletree Rd
Malvern
Vic
3144
Country [2] 279555 0
Australia
Other collaborator category [3] 279556 0
Individual
Name [3] 279556 0
A/Prof Mehmet Yuce
Address [3] 279556 0
Department of Electrical and Computer Systems Engineering
Building 72
Room:229
14 Alliance Lane
Monash University
Clayton
Victoria
3168
Country [3] 279556 0
Australia
Other collaborator category [4] 279557 0
Individual
Name [4] 279557 0
Dr Jean-Michel Redoute
Address [4] 279557 0
Department of Electrical and Computer Systems Engineering
Building 72
Room:229
14 Alliance Lane
Monash University
Clayton
Victoria
3168
Country [4] 279557 0
Australia
Other collaborator category [5] 279583 0
Individual
Name [5] 279583 0
Mr Malcolm Hebblewhite
Address [5] 279583 0
Planet Innovation
436 Edgar Rd
Box Hill
Vic
3128
Country [5] 279583 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297580 0
Cabrini Human Research Ethics Committee
Ethics committee address [1] 297580 0
Ethics committee country [1] 297580 0
Australia
Date submitted for ethics approval [1] 297580 0
01/06/2017
Approval date [1] 297580 0
29/06/2017
Ethics approval number [1] 297580 0
07-19-06-17

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74506 0
A/Prof Mehmet Yuce
Address 74506 0
Department of Electrical and Computer Systems Engineering
Building 72
Room:229
14 Alliance Lane
Monash University
Clayton
Victoria
3168
Country 74506 0
Australia
Phone 74506 0
+61395081550
Fax 74506 0
Email 74506 0
mehmet.yuce@monash.edu
Contact person for public queries
Name 74507 0
Keith Joe
Address 74507 0
Emergency Department
Cabrini
183 Wattletree Rd
Malvern
Vic
3144
Country 74507 0
Australia
Phone 74507 0
+61395081550
Fax 74507 0
Email 74507 0
keith.joe@me.com
Contact person for scientific queries
Name 74508 0
Mehmet Yuce
Address 74508 0
Department of Electrical and Computer Systems Engineering
Building 72
Room:229
14 Alliance Lane
Monash University
Clayton
Victoria
3168
Country 74508 0
Australia
Phone 74508 0
+61399053932
Fax 74508 0
Email 74508 0
mehmet.yuce@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseClinical study of a chest-based cuffless blood pressure monitoring system.2020https://dx.doi.org/10.1002/mds3.10091
Dimensions AIA chest-based continuous cuffless blood pressure method: Estimation and evaluation using multiple body sensors2020https://doi.org/10.1016/j.inffus.2019.07.001
N.B. These documents automatically identified may not have been verified by the study sponsor.