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Trial registered on ANZCTR


Registration number
ACTRN12623001066673
Ethics application status
Approved
Date submitted
13/08/2023
Date registered
5/10/2023
Date last updated
5/10/2023
Date data sharing statement initially provided
5/10/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Remote Observation and Monitoring using bioSensors (ROAM – S) : Validating the Efficacy and Safety of a Remote Monitoring Devices in the Perioperative Period.
Scientific title
Validation of blood pressure monitoring using the Biobeat wireless chest monitor, compared to standard monitoring, in patients in the perioperative period.
Secondary ID [1] 310378 0
None
Universal Trial Number (UTN)
Trial acronym
ROAM -S
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Blood Pressure 330564 0
Condition category
Condition code
Anaesthesiology 327406 327406 0 0
Other anaesthesiology
Cardiovascular 327971 327971 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure

The Device (Biobeat BB-613P) is a non-re-usable chest biosensor (TGA approved) has a similar range of physiological parameters measured and transmitted. This is a Photo Plethysmogram (PPG) based device: the 3cm x 3cm sensor is placed on the patient’s chest (left second intercostal space) using an adhesive patch that is 5cmx5cm and will last approximately 5 days depending on the frequency of data transmission.

In the Cardiopulmonary exercise test (CPET) setting (setting 1) the device will be placed on the patient just prior to the start of the test by the Study investigator or delegate. The device and adhesive will be removed after the test is completed, on the same day, by the study investigator or delegate. The CPET test involves exercising on a ergometer bike for a duration of approximately 10 minutes. During this time, recordings will be taken of blood pressure. The CPET is part of routine clinical care prior to underdoing major surgery.

In the Intraoperative and immediate post operative setting (setting 2), the device will be placed on the patient just prior to the delivery of anaesthesia. It will be placed by the Study investigator or delegate. Anaesthesia will then be induced, and the operation performed as per routine. After the operation, the patient will be moved to the recovery unit. After recovery from anaesthesia is complete, the patient will be transferred to the ward. The device will be removed after 24 hours from when the patient left the recovery unit by the study investigator or delegate.
Intervention code [1] 326777 0
Diagnosis / Prognosis
Comparator / control treatment
Gold-standard medical grade patient monitoring systems with respect to Blood Pressure (Draeger Infinity M540). This is a standalone monitor that uses oscillometry for blood pressure measurement via a blood pressure cuff on the upper arm. This is part of standard care as blood pressure measurements will be routinely required in both setting 1 and 2.
This will be used simultaneously on the same patient as the test device.
Monitoring will be performed for the duration of the CPET test in Setting 1 and for the duration of the anaesthesia, operation, recovery (and ward up to 24 hours after leaving the recovery unit) in Setting 2.
Control group
Active

Outcomes
Primary outcome [1] 335750 0
To assess the precision of a commercially available wearable, wireless, cuffless biosensor (Biobeat BB-613P) when used via a bespoke mobile application (InteliCare Smart Platform) to measure and display blood pressure. This will be assessed by simultaneous comparison of blood pressure output with the gold standard Draeger INfinity M540 blood pressure monitor.
Timepoint [1] 335750 0
Setting 1 : For the duration of the cardiopulmonary exercise test
Setting 2: For the intraoperative period up to 24 hours post-operatively
Primary outcome [2] 336014 0
To assess the accuracy of a commercially available wearable, wireless, cuffless biosensor (Biobeat BB-613P) when used via a bespoke mobile application (InteliCare Smart Platform) to measure and display blood pressure. This will be assessed by simultaneous comparison of blood pressure output with the gold standard Draeger INfinity M540 blood pressure monitor.
Timepoint [2] 336014 0
Setting 1 : For the duration of the cardiopulmonary exercise test
Setting 2: For the intraoperative period up to 24 hours post-operatively
Secondary outcome [1] 426483 0
Record measurements of the heart rate (HR) transmitted from the wireless device during the study period.
Timepoint [1] 426483 0
Setting 1: For the duration of the cardiopulmonary exercise test
Setting 2: For the intraoperation period up to 24 hours post-operatively
Secondary outcome [2] 426484 0
Record measurements of the pulse oximetry (SpO2) transmitted from the wireless device during the study period.
Timepoint [2] 426484 0
Setting 1: For the duration of the cardiopulmonary exercise test
Setting 2: For the intraoperation period up to 24 hours post-operatively
Secondary outcome [3] 426485 0
Record measurements of the temperature (T) transmitted from the wireless device during the study period.
Timepoint [3] 426485 0
Setting 1: For the duration of the cardiopulmonary exercise test
Setting 2: For the intraoperation period up to 24 hours post-operatively
Secondary outcome [4] 426486 0
Record measurements of respiratory rate (RR) transmitted from the wireless device during the study period.
Timepoint [4] 426486 0
Setting 1: For the duration of the cardiopulmonary exercise test
Setting 2: For the intraoperation period up to 24 hours post-operatively

Eligibility
Key inclusion criteria
Setting 1: Included in the Prehabilitation Service at the PMCC with an M-DASI > 3 (modified duke activity score index) .

Setting 2: Scheduled to have any surgery greater than one-hour duration with anticipated need for vasopressor drugs perioperatively and monitored in the 23-hour unit on a regular monitored schedule for 24 hours post-operatively.
Minimum age
50 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria for Setting 1:

Unable to sit on an exercise bike and maintain cadence.
Contra-indications to Cardiopulmonary Exercise Test (CPET)
Cardiac Rhythm abnormality including the presence of AF
Allergy to adhesive tapes and dressings


Exclusion Criteria for Setting 2:

Surgery is planned to be less than one-hour duration or greater than 4 hours duration.
Planned Intensive Care or High Dependency Unit admission post-operatively
Less than one overnight stay in hospital
Allergy to adhesive tapes and dressings

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The detailed statistical methodology is outlined in IEEE Standard 1708a™-2019 . To analyse the data, mean absolute difference (MAD) and mean absolute percentage difference (MAPD) will be computed in addition to 95% confidence intervals around the MAD/MAPD.
After testing the device on 20 subjects in each setting, the differences between the readings from the test device and the reference measurements should be within 7 mmHg for both systolic blood pressure (SBP) and diastolic blood pressure (DBP) for the 3 levels of testing (static test, test with BP change from calibration point, and test after a period of time from calibration).
The accuracy of the device is then determined based on the mean absolute difference (MAD) between the readings from the test device and the reference measurements for both SBP and DBP. The accuracy is graded based on a table, where a Grade A device has an MAD of 5 mmHg, Grade B for MAD of 5-6 mmHg, Grade C for MAD of 6-7 mmHg, and Grade D for MAD of 7 mmHg.
Since the accuracy of the device can vary at different blood pressure levels, a mean arterial pressure difference (MAPD) is used instead of a constant accuracy limit. This means that the relative difference between the readings from the device and the reference measurement is used instead of the absolute difference. The report should also include the mean difference (MD), standard deviation (SD), and critical difference (CP) values to ensure that the accuracy is interpreted correctly across different evaluation systems.
Precision will be calculated by dividing the number of values with MAD less than 7mmHg with the total number of values.
If the device does not meet this requirement, then a decision to fail the device can be made at this point and the study repeated if an easily rectifiable cause for failure can be identified.

Accuracy at different BP change levels: MAD at different BP change levels should be within 7 mmHg for SBP and DBP analysed separately. Precision will be calculated by dividing the number of values with MAD less than 7mmHg with the total number of values.


Accuracy after a certain period of time from calibration: The accuracy should be consistent with the pass/fail criteria specified in the IEEE standard.

Accuracy at different BP levels: Except Stage 2 hypertension, MAD at different BP classification categories determined by subjects’ entry BP should be within 6 mmHg for SBP and DBP measurement analysed separately.

Categorical variables will be summarised using frequency and percentage. Continuous variables will be summarised using mean and standard deviation (SD) or median and interquartile range (IQR) as appropriate. The 95% limits of agreement between BP from the App via the individual sensors and standard monitors will be analyzed using a Bland-Altman plot. To account for several paired measurements for each participant, the analysis will be adjusted to repeated observations derived from the same participants, using the appropriate bounds.

The bias (mean difference), standard deviation (SD), 95% LOA, and plot will be derived using SPSS for Windows (version 23 – IBM). Paired BP data from each participant will be matched based on time stamps as logged by the recording software.
Since the sensors record on a regular interval it will be matched to the corresponding physiological signals from the hospital’s wired monitors.
To account for several paired measurements for each participant, the analysis will be adjusted to account for repeated observations derived from the same participants.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/10/2023
Actual
Date of last participant enrolment
Anticipated
29/12/2023
Actual
Date of last data collection
Anticipated
1/01/2024
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25374 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 41104 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 314209 0
Commercial sector/Industry
Name [1] 314209 0
auDA Foundation
Country [1] 314209 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
305 Grattan StreetParkville3052MelbourneVictoria
Country
Australia
Secondary sponsor category [1] 316542 0
None
Name [1] 316542 0
Address [1] 316542 0
Country [1] 316542 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313334 0
Peter MacCallum Cancer Centre Human Research ethics Committee
Ethics committee address [1] 313334 0
305 Grattan StreetParkville 3052MelbourneVIC
Ethics committee country [1] 313334 0
Australia
Date submitted for ethics approval [1] 313334 0
Approval date [1] 313334 0
31/07/2023
Ethics approval number [1] 313334 0

Summary
Brief summary
Clinicians and patients require means by which they can share data related to their care and in turn have steps taken to redirect care when required in real-time, before and after surgery. This data includes physiological parameters of heart rate, body temperature, blood pressure, breathing rate and oxygen saturation levels, Our vision is to co-design a digital solution aimed at providing an efficacious, safe, effective, and equitable means of communication between patients and healthcare providers during the perioperative period.

The Biobeat BB-613P device, a wireless wearable chest monitor, utilises photoplethysmography (PPG) technology, and has already been used in blood pressure validation studies in both the inpatient and outpatient setting, including the ICU. However, validation for use of this device in the immediate postoperative setting on surgical wards has not been previously conducted. As the PPG technology has the unique and novel ability for cuffless blood pressure monitoring, we aim to validate the accuracy and precision of this parameter in our clinical setting, in the Cardiopulmonary Exercise laboratory and in the theatre and early post-operative setting, using the approach described by the Institute of Electronics and Electronics Engineers (IEEE) Standard 1708a™-2019.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127774 0
Dr Hilmy Ismail
Address 127774 0
Peter MacCallum Cancer Centre, 305 Grattan StParkville 3052MelbourneVIC
Country 127774 0
Australia
Phone 127774 0
+61 0406958537
Fax 127774 0
Email 127774 0
[email protected]
Contact person for public queries
Name 127775 0
Hilmy Ismail
Address 127775 0
Peter MacCallum, Cancer Centre, 305 Grattan StParkville 3052MelbourneVIC
Country 127775 0
Australia
Phone 127775 0
+61 0406958537
Fax 127775 0
Email 127775 0
[email protected]
Contact person for scientific queries
Name 127776 0
Hilmy Ismail
Address 127776 0
Peter MacCallum Cancer Centre, 305 Grattan StParkville 3052MelbourneVIC
Country 127776 0
Australia
Phone 127776 0
+61 0406958537
Fax 127776 0
Email 127776 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
as per protocol, not required


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
No additional documents have been identified.