Blood PressureNCT03493867
Verification of The Cloud DX Vitaliti™ Continuous Vital Sign Monitor (CVSM): Non-invasive Blood Pressure Component
A study testing Vitaliti in people with Blood Pressure, run by Population Health Research Institute at 1 site in Canada.
Trial summary
The purpose of this study is the verification of Cloud-DX Vitaliti™ Continuous Automated Non-Invasive Blood Pressure Monitor for Clinical Use and Self Measurement according to standards laid out by IEEE Std 1708 and AAMI-ISO 81060-2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Vitaliti
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteCanada
- Study dates
- 9 Aug 2018to 6 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥18 years of age;
- Patient has undergone major cardiac or vascular surgery and has been admitted post-op to the cardiac surgical intensive care unit (CICU) or vascular surgery step down unit with an arterial line in place
Who cannot join
- Patients < 18 years of age;
- Pregnant;
- Current arrhythmia
- Blood pressure outside of test range for phase (refer to table 1)
- Allergy to device contact adhesive (e.g. ECG leads)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Verification Protocol for The Cloud DX Vitaliti™ Continuous Vital Sign Monitor (CVSM): Non-invasive Blood Pressure Component for Clinical Use and Self Measurement According to the American Safety in Medical Technology and the IEEE
The purpose of this study is the verification of Cloud-DX Vitaliti™ Continuous Automated Non-Invasive Blood Pressure Monitor for Clinical Use and Self Measurement according to standards laid out by IEEE Std 1708 and AAMI-ISO 81060-2.
Read the detailed description
Several automated vital sign measurement systems have been developed recently; however, non-invasive continuous blood pressure monitoring continues to be a major limitation. To circumvent the limitations of current systems of interval hemodynamic measurement and increasing demands on health care providers, a non-invasive automated continuous vital sign monitor that can integrate into hospital early warning systems and warn health care providers of deteriorating vital sign parameters would be of significant value and a major advance for current hospital monitoring systems.
Cloud-DX Vitaliti™ is a new low profile automated vital sign monitor, which includes a continuous non-invasive blood pressure measurement system. Additional parameters are also measured. Paired with companion software from cloud based computing, Vitaliti™ features a user friendly interface, onboard radios for communication with smartphones/tablets/personal computers, and several sensors.
Cloud-DX Vitaliti™ has undergone preliminary testing and is now ready for verification to achieve compliance with AAMI/ISO and IEEE standards of medical grade device. At the Hamilton General Hospital (HGH), Cardiac Surgical Intensive Care Unit (CICU) and Vascular Surgical Step Down Units, arterial catheters are standard of care and performed on most patients for variable periods of post-operative recovery. Within this setting, the IEEE Std 1708 and AAMI-ISO 81060-2 would be fully met. Furthermore, the cardiovascular surgical caseloads at HGH would provide sufficient test subjects to validate VitalitiTM in a timely fashion.
- Conditions
- Blood Pressure
- Being tested
- Vitaliti
- Keywords
- Non-invasive blood pressure monitoring, Wearable device, Medical device verification study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitalitiDevice
Measurements recorded by the Vitaliti device will be compared to the recordings from the arterial catheter.
| Study group | Role | What they receive |
|---|---|---|
| Vitaliti | Other | The subject's blood pressure will be simultaneously determined and recorded using the invasive arterial line blood pressure reading and the test Vitaliti device readings. Receives: Device: Vitaliti |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Determining the accuracy of non-invasive blood pressure measurement compared to invasive blood pressure. A detailed analysis will be conducted on the invasive blood pressure to verify accuracy as defined in the ISO 81060-2 Standard.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start9 Aug 2018
- Primary completion6 Nov 2019
- Study completion6 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Vitaliti Continuous Vital Sign Monitoring Device - Version 2.0
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Federal Economic Development Agency for Southern Ontario (FedDev Ontario)
- Responsible party
- Principal investigator, Mike McGillion, Population Health Research Institute
- Investigators
- Michael McGillion, RN, PhD, Principal investigator, School of Nursing, Faculty of Health Sciences, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03493867
- Sponsor's protocol ID
- STP-VIT-002
- Status last verified
- Mar 2020
- First submitted
- 16 Mar 2018
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data which will be collected is only valid for the verification of this particular device.
Publications
McGillion MH, Dvirnik N, Yang S, Belley-Cote E, Lamy A, Whitlock R, Marcucci M, Borges FK, Duceppe E, Ouellette C, Bird M, Carroll SL, Conen D, Tarride JE, Harsha P, Scott T, Good A, Gregus K, Sanchez K, Benoit P, Owen J, Harvey V, Peter E, Petch J, Vincent J, Graham M, Devereaux PJ. Continuous Noninvasive Remote Automated Blood Pressure Monitoring With Novel Wearable Technology: A Preliminary Validation Study. JMIR Mhealth Uhealth. 2022 Feb 28;10(2):e24916. doi: 10.2196/24916.
PubMed 34876396
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verification Protocol for The Cloud DX Vitaliti™ Continuous Vital Sign Monitor (CVSM): Non-invasive Blood Pressure Component for Clinical Use and Self Measurement According to the American Safety in Medical Technology and the IEEE
- ClinicalTrials.gov ID
- NCT03493867
- Acronym / sponsor ID
- STP-VIT-002
- Conditions
- Blood Pressure
- Keywords
- Non-invasive blood pressure monitoring, Wearable device, Medical device verification study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Collaborators
- Federal Economic Development Agency for Southern Ontario (FedDev Ontario)
- Study start
- 9 Aug 2018 (actual)
- Primary completion
- 6 Nov 2019 (actual)
- Study completion
- 6 Nov 2019 (actual)
- First posted
- 11 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is the verification of Cloud-DX Vitaliti™ Continuous Automated Non-Invasive Blood Pressure Monitor for Clinical Use and Self Measurement according to standards laid out by IEEE Std 1708 and AAMI-ISO 81060-2.
Detailed description
Several automated vital sign measurement systems have been developed recently; however, non-invasive continuous blood pressure monitoring continues to be a major limitation. To circumvent the limitations of current systems of interval hemodynamic measurement and increasing demands on health care providers, a non-invasive automated continuous vital sign monitor that can integrate into hospital early warning systems and warn health care providers of deteriorating vital sign parameters would be of significant value and a major advance for current hospital monitoring systems.
Cloud-DX Vitaliti™ is a new low profile automated vital sign monitor, which includes a continuous non-invasive blood pressure measurement system. Additional parameters are also measured. Paired with companion software from cloud based computing, Vitaliti™ features a user friendly interface, onboard radios for communication with smartphones/tablets/personal computers, and several sensors.
Cloud-DX Vitaliti™ has undergone preliminary testing and is now ready for verification to achieve compliance with AAMI/ISO and IEEE standards of medical grade device. At the Hamilton General Hospital (HGH), Cardiac Surgical Intensive Care Unit (CICU) and Vascular Surgical Step Down Units, arterial catheters are standard of care and performed on most patients for variable periods of post-operative recovery. Within this setting, the IEEE Std 1708 and AAMI-ISO 81060-2 would be fully met. Furthermore, the cardiovascular surgical caseloads at HGH would provide sufficient test subjects to validate VitalitiTM in a timely fashion.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Vitaliti Continuous Vital Sign Monitoring Device - Version 2.0
| Arm | Type | Receives |
|---|---|---|
| Vitaliti | Other | Device: VitalitiThe subject's blood pressure will be simultaneously determined and recorded using the invasive arterial line blood pressure reading and the test Vitaliti device readings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients ≥18 years of age;
- Patient has undergone major cardiac or vascular surgery and has been admitted post-op to the cardiac surgical intensive care unit (CICU) or vascular surgery step down unit with an arterial line in place
Key exclusion criteria (5 listed)
- Patients < 18 years of age;
- Pregnant;
- Current arrhythmia
- Blood pressure outside of test range for phase (refer to table 1)
- Allergy to device contact adhesive (e.g. ECG leads)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VitalitiMeasurements recorded by the Vitaliti device will be compared to the recordings from the arterial catheter. | Device | Vitaliti |
Primary outcome
Blood pressure
Time frame: 30 minutes
Determining the accuracy of non-invasive blood pressure measurement compared to invasive blood pressure. A detailed analysis will be conducted on the invasive blood pressure to verify accuracy as defined in the ISO 81060-2 Standard.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Derived from this study: PubMed 34876396McGillion MH, Dvirnik N, Yang S, Belley-Cote E, Lamy A, Whitlock R, Marcucci M, Borges FK, Duceppe E, Ouellette C, Bird M, Carroll SL, Conen D, Tarride JE, Harsha P, Scott T, Good A, Gregus K, Sanchez K, Benoit P, Owen J, Harvey V, Peter E, Petch J, Vincent J, Graham M, Devereaux PJ. Continuous Noninvasive Remote Automated Blood Pressure Monitoring With Novel Wearable Technology: A Preliminary Validation Study. JMIR Mhealth Uhealth. 2022 Feb 28;10(2):e24916. doi: 10.2196/24916.
- Individual participant dataSharing planned: Undecided. The data which will be collected is only valid for the verification of this particular device.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael McGillion, RN, PhD principal investigator
School of Nursing, Faculty of Health Sciences, McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitaliti in people with Blood Pressure, run by Population Health Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03493867, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020.