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Trial registered on ANZCTR


Registration number
ACTRN12621000028808
Ethics application status
Approved
Date submitted
23/10/2020
Date registered
14/01/2021
Date last updated
14/01/2021
Date data sharing statement initially provided
14/01/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical Validation of a Smart Wearable Device to Monitor Cardiac and Respiratory Vital Signs using Morphic Band Sensors “ASPEN Trial”
Scientific title
Clinical Validation of a Smart Wearable Device to Monitor Cardiac and Respiratory Vital Signs using Morphic Band Sensors in healthy volunteers and ICU patients on ventilation.
Secondary ID [1] 302613 0
SAIIV-CIP-02
Universal Trial Number (UTN)
Trial acronym
ASPEN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac Vital Sign 319502 0
Respiratory Vital Signs 319503 0
Condition category
Condition code
Cardiovascular 317462 317462 0 0
Other cardiovascular diseases
Respiratory 317463 317463 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a pivotal validation study of the Saiiv wearable vital signs monitor and App. The Saiiv wearable vita signs monitor is a waist belt worn around the chest and upper abdominal region. Validation of cardiac and respiratory vital signs will be conducted against gold standard TGA approved devices in 40 healthy volunteers and 40 ventilated patients in ICU.

Validation will involve healthy volunteers having vital signs assessed laying down, sitting and during light activity. ICU patients will wear the device and vital signs will be monitored. ICU participants will not be required to complete any tasks. Vital signs monitoring will be conducted by a study coordinator and healthcare worker (nurse or doctor).

Health volunteers will be monitored in-clinic over a 2 hour period and if consented will take the study device home and wear it for 2 weeks (minimum of 2-hours/day). They will then return to the research site and conduct a second 2-hour in-clinic monitoring study after which they will be exited form the study. ICU participants will be fitted with a study monitoring device in ICU and monitored for a two-hour period after which they will be exited form the study.

Participants will not be required to interact with the App during the validation (in-clinic) assessments. Healthy volunteers who consent to the home assessment will download a copy of the App on their smart phone and will be able to interact with the App.

The study will occur in the hospital/ward setting and in ICU.
Intervention code [1] 318898 0
Early Detection / Screening
Comparator / control treatment
Vital signs from the study device will be comparted to vital signs monitoring equipment in the hospital (TGA approved) including ventilator, ECG, trans thoracic echocardiography, tympanic temperature, infra-red non contact handheld thermometer, photoplethysmography, IntelliVue monitor and stethoscope.
Control group
Active

Outcomes
Primary outcome [1] 325496 0
Respiratory rate (RR) breaths per minute from investigational device compared to gold standard output.
Timepoint [1] 325496 0
Day 1 and Day 14.
Primary outcome [2] 325792 0
Temperature (skin) in degrees Celsius from investigational device compared to gold standard output.
Timepoint [2] 325792 0
Day 1 and Day 14.
Primary outcome [3] 325793 0
Heart Rate (HR) beats per minute from investigational device compared to gold standard output.
Timepoint [3] 325793 0
Day 1 and Day 14.
Secondary outcome [1] 388156 0
Cardiac Output (CO) - Primary endpoint L/min from investigational device compared to gold standard output.
Timepoint [1] 388156 0
Day 1 and Day 14.
Secondary outcome [2] 388157 0
Respiratory Effort (RE) - Primary endpoint concordance from investigational device compared to gold standard.
Timepoint [2] 388157 0
Day 1 and Day 14.
Secondary outcome [3] 388158 0
Change in Tidal Volume (TV) - Primary endpoint concordance from investigational device compared to gold standard.
Timepoint [3] 388158 0
Day 1 and Day 14.
Secondary outcome [4] 389147 0
Participant orientation/position eg standing, laying down - Primary endpoint concordance from investigational device compared to gold standard.
Timepoint [4] 389147 0
Day 1 and Day 14
Secondary outcome [5] 389148 0
Validation of study device ECG against gold standard device concordance from investigational device compared to gold standard.
Timepoint [5] 389148 0
Day 1 and Day 14
Secondary outcome [6] 389149 0
Safety data review including adverse events and serious adverse events.. Adverse events will be collected form participant interviews (e.g. follow-up visits) and if applicable, medical records.
Timepoint [6] 389149 0
Day 1 to Day 14
Secondary outcome [7] 389150 0
Usability data for study device and App derived form user questionnaires. The questionnaire has been developed by the sponsor and is not validated.
Timepoint [7] 389150 0
Day 1 to Day 14.

Eligibility
Key inclusion criteria
1. Healthy Volunteers must have given written informed consent before any study related activities are carried out and must be able to understand the full nature and purpose of the trial including possible risks. Ventilated participants will not be consented however patient’s Person Responsible will be informed of the study and asked to provide consent.
2. Female participants of childbearing potential must not be pregnant or nursing at the time of enrolment.
3. Must be able to be fitted with the device.
4. Provision of use of a Smart phone for the duration of the study, and willingness to download the App for at-home study.
5. If a Healthy participants who consent to the at-home study must be willing to use personal WIFI for App use and phone which has Bluetooth.
6. If in ICU arm admitted for ventilatory support using invasive ventilation as part of standard of care.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Known skin sensitivities or allergies to elasticated products.
2. Broken skin or rashes on torso (where devices will be in contact with the skin).
3. Participant who, in the opinion of the investigator, is not a good candidate for the study.
4. Cardiac pacemaker or implantable defibrillator, known to require defibrillation.
5. Any medical intervention that would interfere with the study.
6. Participant with surgical wounds/dressing precluding the appropriate placement of the investigational device.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The agreement between vital signs, measured by the study monitoring device and a gold standard, will be assessed by Lin’s concordance correlation coefficient (CCC). It is expected that CCC will be around 0.95 between paired data (study monitoring device vs gold standard), with the lower side of the 95% confidence interval (CI) more than 0.85. With a probability of 90% (power) to obtain the 95% CI, a sample size of 34 (i.e. 34 paired data) is needed in Arm 1 and Arm 2 (i.e. total of 68 participants). To account for a drop out of 20%, a sample size of 41 is needed in each arm (i.e. total of 82 participants).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2021
Actual
Date of last participant enrolment
Anticipated
1/06/2021
Actual
Date of last data collection
Anticipated
30/06/2021
Actual
Sample size
Target
82
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 17894 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 31751 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 307043 0
Commercial sector/Industry
Name [1] 307043 0
Medical Monitoring Solutions Pty Ltd
Country [1] 307043 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Medical Monitoring Solutions Pty Ltd
Address
Suite 1402B, 275 Alfred Street, North Sydney, NSW. 2060, Australia.
Country
Australia
Secondary sponsor category [1] 307611 0
None
Name [1] 307611 0
Address [1] 307611 0
Country [1] 307611 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307170 0
South Western Sydney Local Health District
Ethics committee address [1] 307170 0
Level 2, UNSW Clinical School
Liverpool Hospital
NSW 2170
Ethics committee country [1] 307170 0
Australia
Date submitted for ethics approval [1] 307170 0
04/09/2020
Approval date [1] 307170 0
22/10/2020
Ethics approval number [1] 307170 0

Summary
Brief summary
The purpose of the study is to validate the cardiac and respiratory vital signs form the Saiiv Medical vital signs monitoring kit against gold standard vital signs monitoring devices which have been approved by the Therapeutic Goods Administration (TGA).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106278 0
Prof Anders Aneman
Address 106278 0
Intensive Care Unit
Liverpool Hospital
Locked Bag 7103
Liverpool BC NSW 1871
Country 106278 0
Australia
Phone 106278 0
+61 2 8738 3400
Fax 106278 0
+61 2 8738 3551
Email 106278 0
[email protected]
Contact person for public queries
Name 106279 0
Neil Anderson
Address 106279 0
Medical Monitoring Solutions Pty Ltd
Suite 1402B, 275 Alfred Street,
North Sydney, NSW, 2060
Country 106279 0
Australia
Phone 106279 0
+61 2 8317 5460
Fax 106279 0
+61 2 8317 5461
Email 106279 0
[email protected]
Contact person for scientific queries
Name 106280 0
Neil Anderson
Address 106280 0
Medical Monitoring Solutions Pty Ltd
Suite 1402B, 275 Alfred Street,
North Sydney, NSW, 2060
Country 106280 0
Australia
Phone 106280 0
+61 2 8317 5460
Fax 106280 0
+61 2 8317 5461
Email 106280 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
Commercial in Confidence. Data will be published in a scientific journal.


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.