Blood PressureNCT05224011
Non-invasive Continuous Blood Pressure Monitoring
A study testing Boppli Infant Blood Pressure Monitor in people with Blood Pressure, run by PyrAmes Inc. at 1 site in Canada.
Trial summary
The Boppli device was designed to provide continuous non-invasive blood pressure (cNIBP) monitoring for infants, including neonates, in intensive care settings by detecting systolic, diastolic, and mean arterial blood pressure values comparable to that of an invasive arterial line (IAL) within published accuracy… Read more about this study
- Who is it for?
- Ages Up to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Boppli Infant Blood Pressure Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- 22 Jun 2022to 22 Sep 2022
- 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 Up to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Groups 1 - 4:
- Pediatric patients less than 1 year of age and less than 5000 g in weight (primary target)
- Requires intra-arterial blood pressure monitoring
- Group 5:
- Pediatric patients
- Requires intra-arterial blood pressure monitoring
- NOTE: Under no circumstance should an invasive arterial line be implanted in a patient due to this study, if not medically necessary.
Who cannot join
- Skin conditions that limit the placement of the device
- Patients connected to or treated by other devices that may alter the pulse waveform
- Patients with a cardiac or vascular malformation that results in an abnormal waveform inappropriate to be considered a reference standard.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Foothills Medical Center Neonatal Intensive Care Unit, NICU 51
Calgary, Alberta, T2N 4N1
About this study
Official title: A Prospective Study to Evaluate the Safety and Effectiveness of the Boppli™ in Measuring Mean Arterial Pressure (MAP), Systolic Blood Pressure (SBP), and Diastolic Blood Pressure (DBP) as Compared to an Invasive Arterial Reference
The Boppli device was designed to provide continuous non-invasive blood pressure (cNIBP) monitoring for infants, including neonates, in intensive care settings by detecting systolic, diastolic, and mean arterial blood pressure values comparable to that of an invasive arterial line (IAL) within published accuracy criteria. The device consists of an array of capacitive sensors contained in a soft, flexible, biocompatible band. It applies proprietary algorithms to capacitance detections to generate accurate systolic, diastolic, and mean arterial blood pressure and waveform data, then communicates the data to an external device via Bluetooth Low Energy for storage and display. It may be applied to the patient's arm or foot on either side of the body, which is advantageous for infants whose bodies provide limited surface area for medical devices or equipment. It does not require high skin pressure when correctly placed. The device is intended for single use of up to 72 hours and is discarded following use.
Read the detailed description
The purpose of this study is to validate PyrAmes's non-invasive blood pressure measurements against invasive blood pressure measurements taken with a reference device that is routinely used in a hospital setting, is generally regarded as accurate, and is routinely used in the diagnosis and treatment of patients. In this case, the reference device is the invasive arterial line, which is routinely used in the care of infants in intensive care settings to collect accurate, continuous invasive blood pressure measurements.
The specific aim of this study is to record data obtained by use of the Boppli device, along with invasive measurements of blood pressure, for use in validating the Boppli device measurements and algorithm. The changes in capacitance will serve as an input for the Boppli algorithm and systolic, diastolic, and mean arterial pressure will be output. The measurements generated from the non-invasive Boppli Device will be validated against the invasive measurements from the reference device. This is a prospective, multi-center clinical study to validate the effectiveness of the Boppli Blood Pressure Monitor as compared to an invasive arterial reference. The study will evaluate the accuracy and precision of the Boppli system for continuous blood pressure monitoring by comparing SBP (systolic blood pressure), DBP (diastolic blood pressure), and MAP (mean arterial pressure) against the reference methodology.
Invasive arterial lines (IAL) were selected as the comparator for this study. IALs are the current gold standard for continuous blood pressure monitoring for infants in intensive care settings. Sphygmomanometers are widely used for non-invasive blood pressure monitoring among other populations but have documented issues with accuracy in patients with very low blood pressures, which includes many neonates and pediatric patients. Due to their potentially low accuracy in detecting blood pressure in infants, the manual sphygmomanometer is not regarded as an appropriate comparator for the Boppli device.
As stated in reference standards ISO 81060-2 and ANSI SP10, intra-arterial methods should not be used for subjects solely for the purpose of validating instrument performance. However, the SP10 standard states that in validation studies in children less than 3 years of age, the intra-arterial method should be used as the reference standard. In addition, it is noted that ISO 81060-2 explicitly states that children less than 3 years of age should not be included in clinical investigations using auscultatory reference readings. Therefore, this study will be conducted on clinical subjects (neonates/infants) in whom an intra-arterial line has already been placed for reasons other than validating instrument performance.
Primary objective: To assess the accuracy and precision of the Boppli system in measuring SBP, DBP, and MAP as compared to an invasive arterial line for continuous blood pressure monitoring.
Secondary Objective: To assess the safety of the Boppli system in a clinical setting.
Methods: Data to assess device efficacy, subject safety, and subject demographics will be collected from the Investigational sites. Data will be collected using an electronic data collection system (EDC) designed to comply with 21 CFR Part 11 and will be recorded into the electronic Case Report Form (eCRF). Primary source documentation will come directly from the subject's medical record
- Conditions
- Blood Pressure
- Being tested
- Boppli Infant Blood Pressure Monitor
- Keywords
- Neonates, Blood Pressure monitoring, Medical Device, Non-Invasive Blood Pressure Monitoring, Invasive Arterial Lines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boppli Infant Blood Pressure MonitorDevice
The intervention is a medical device for the non-invasive measurement of blood pressure in infants
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | The Boppli device will be applied to the patients' arm or foot on either side of the body and is intended for single use of up to 72 hours and is discarded following use. The device will only be used in patients requiring continuous blood pressure monitoring, through the use of an invasive arterial line (IAL), to compare the data obtained by the Boppli to that obtained by the IAL. Receives: Device: Boppli Infant Blood Pressure Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the accuracy and precision of the Boppli System in continuous blood pressure monitoring
The primary objective of this pivotal study is to assess the accuracy and precision of the Boppli system in measuring systolic blood pressure (SBP), diastolic blood pressure (DBP) and mean arterial pressure (MAP), as compared to an invasive arterial line for continuous blood pressure monitoring in infants.
The following steps will be performed specifically to collect data for this study:
- Boppli will be used alongside IALs onsite to collect blood pressure measurements, as well as pulse waveforms.
- Continuous data from the IAL and Boppli will be paired for comparison
- The total duration of data collection is expected to be approximately 6 hours with some patients remaining in the study up to 72 hours. However, subjects will not be required to remain in the study should clinical care indicate that the IAL should be removed.
- Observed rapid changes in blood pressure will be collected and the Boppli's accuracy in detecting these changes will be compared against IAL
Measured: 6 - 72 Hours
Secondary outcomes (1)
Assess the safety of the Boppli System in a clinical setting
The secondary objective is to assess the safety of the Boppli System in a clinical setting. This will be done by collecting and analyzing all adverse events observed during the study. Information on the usability of the device and its impact on workflow will also be collected.
The following steps will be performed specifically to collect data for this study:
- Boppli will be used alongside IALs onsite to collect blood pressure measurements, as well as pulse waveforms.
- Continuous data from the IAL and Boppli will be paired for comparison
- The total duration of data collection is expected to be approximately 6 hours with some patients remaining in the study up to 72 hours. However, subjects will not be required to remain in the study should clinical care indicate that the IAL should be removed.
- Observed rapid changes in blood pressure will be collected and the Boppli's accuracy in detecting these changes will be compared against IAL
Measured: 6 - 72 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start22 Jun 2022
- Primary completion22 Sep 2022
- Study completion22 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study is a single-arm study in which patient measurements will be obtained using both the investigational device-Boppli-as well as traditional blood pressure measurement collected via IAL.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- PyrAmes Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Calgary
- Responsible party
- Sponsor
- Investigators
- Kamran Yusuf, Ph.D., Principal investigator, University of Calgary - Department of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05224011
- Sponsor's protocol ID
- PyrAmes-2021-01
- Status last verified
- Jun 2022
- First submitted
- 4 Jan 2022
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Evaluate the Safety and Effectiveness of the Boppli™ in Measuring Mean Arterial Pressure (MAP), Systolic Blood Pressure (SBP), and Diastolic Blood Pressure (DBP) as Compared to an Invasive Arterial Reference
- ClinicalTrials.gov ID
- NCT05224011
- Acronym / sponsor ID
- PyrAmes-2021-01
- Conditions
- Blood Pressure
- Keywords
- Neonates, Blood Pressure monitoring, Medical Device, Non-Invasive Blood Pressure Monitoring, Invasive Arterial Lines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- PyrAmes Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Calgary
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- 22 Sep 2022 (actual)
- Study completion
- 22 Sep 2022 (actual)
- First posted
- 4 Feb 2022 (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 Boppli device was designed to provide continuous non-invasive blood pressure (cNIBP) monitoring for infants, including neonates, in intensive care settings by detecting systolic, diastolic, and mean arterial blood pressure values comparable to that of an invasive arterial line (IAL) within published accuracy criteria. The device consists of an array of capacitive sensors contained in a soft, flexible, biocompatible band. It applies proprietary algorithms to capacitance detections to generate accurate systolic, diastolic, and mean arterial blood pressure and waveform data, then communicates the data to an external device via Bluetooth Low Energy for storage and display. It may be applied to the patient's arm or foot on either side of the body, which is advantageous for infants whose bodies provide limited surface area for medical devices or equipment. It does not require high skin pressure when correctly placed. The device is intended for single use of up to 72 hours and is discarded following use.
Detailed description
The purpose of this study is to validate PyrAmes's non-invasive blood pressure measurements against invasive blood pressure measurements taken with a reference device that is routinely used in a hospital setting, is generally regarded as accurate, and is routinely used in the diagnosis and treatment of patients. In this case, the reference device is the invasive arterial line, which is routinely used in the care of infants in intensive care settings to collect accurate, continuous invasive blood pressure measurements.
The specific aim of this study is to record data obtained by use of the Boppli device, along with invasive measurements of blood pressure, for use in validating the Boppli device measurements and algorithm. The changes in capacitance will serve as an input for the Boppli algorithm and systolic, diastolic, and mean arterial pressure will be output. The measurements generated from the non-invasive Boppli Device will be validated against the invasive measurements from the reference device. This is a prospective, multi-center clinical study to validate the effectiveness of the Boppli Blood Pressure Monitor as compared to an invasive arterial reference. The study will evaluate the accuracy and precision of the Boppli system for continuous blood pressure monitoring by comparing SBP (systolic blood pressure), DBP (diastolic blood pressure), and MAP (mean arterial pressure) against the reference methodology.
Invasive arterial lines (IAL) were selected as the comparator for this study. IALs are the current gold standard for continuous blood pressure monitoring for infants in intensive care settings. Sphygmomanometers are widely used for non-invasive blood pressure monitoring among other populations but have documented issues with accuracy in patients with very low blood pressures, which includes many neonates and pediatric patients. Due to their potentially low accuracy in detecting blood pressure in infants, the manual sphygmomanometer is not regarded as an appropriate comparator for the Boppli device.
As stated in reference standards ISO 81060-2 and ANSI SP10, intra-arterial methods should not be used for subjects solely for the purpose of validating instrument performance. However, the SP10 standard states that in validation studies in children less than 3 years of age, the intra-arterial method should be used as the reference standard. In addition, it is noted that ISO 81060-2 explicitly states that children less than 3 years of age should not be included in clinical investigations using auscultatory reference readings. Therefore, this study will be conducted on clinical subjects (neonates/infants) in whom an intra-arterial line has already been placed for reasons other than validating instrument performance.
Primary objective: To assess the accuracy and precision of the Boppli system in measuring SBP, DBP, and MAP as compared to an invasive arterial line for continuous blood pressure monitoring.
Secondary Objective: To assess the safety of the Boppli system in a clinical setting.
Methods: Data to assess device efficacy, subject safety, and subject demographics will be collected from the Investigational sites. Data will be collected using an electronic data collection system (EDC) designed to comply with 21 CFR Part 11 and will be recorded into the electronic Case Report Form (eCRF). Primary source documentation will come directly from the subject's medical record
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study is a single-arm study in which patient measurements will be obtained using both the investigational device-Boppli-as well as traditional blood pressure measurement collected via IAL.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Boppli Infant Blood Pressure MonitorThe Boppli device will be applied to the patients' arm or foot on either side of the body and is intended for single use of up to 72 hours and is discarded following use. The device will only be used in patients requiring continuous blood pressure monitoring, through the use of an invasive arterial line (IAL), to compare the data obtained by the Boppli to that obtained by the IAL. |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Pediatric patients less than 1 year of age and less than 5000 g in weight (primary target)
- Requires intra-arterial blood pressure monitoring
- Pediatric patients
- Requires intra-arterial blood pressure monitoring
- NOTE: Under no circumstance should an invasive arterial line be implanted in a patient due to this study, if not medically necessary.
Key exclusion criteria (3 listed)
- Skin conditions that limit the placement of the device
- Patients connected to or treated by other devices that may alter the pulse waveform
- Patients with a cardiac or vascular malformation that results in an abnormal waveform inappropriate to be considered a reference standard.
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 |
|---|---|---|
| Boppli Infant Blood Pressure MonitorThe intervention is a medical device for the non-invasive measurement of blood pressure in infants | Device | Experimental |
Primary outcome
Assess the accuracy and precision of the Boppli System in continuous blood pressure monitoring
Time frame: 6 - 72 Hours
The primary objective of this pivotal study is to assess the accuracy and precision of the Boppli system in measuring systolic blood pressure (SBP), diastolic blood pressure (DBP) and mean arterial pressure (MAP), as compared to an invasive arterial line for continuous blood pressure monitoring in infants. The following steps will be performed specifically to collect data for this study: * Boppli will be used alongside IALs onsite to collect blood pressure measurements, as well as pulse waveforms. * Continuous data from the IAL and Boppli will be paired for comparison * The total duration of data collection is expected to be approximately 6 hours with some patients remaining in the study up to 72 hours. However, subjects will not be required to remain in the study should clinical care indicate that the IAL should be removed. * Observed rapid changes in blood pressure will be collected and the Boppli's accuracy in detecting these changes will be compared against IAL
1 secondary outcome
Assess the safety of the Boppli System in a clinical setting
Time frame: 6 - 72 Hours
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 22 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Blood Pressure
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
RecruitingPhase 3
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
Chronic Kidney Disease and Hypertension
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingPhase 4
Hematological Safety of Dipyrone Versus Paracetamol After Dental Extractions
Hematologic Test, Agranulocytosis
Not yet recruiting
Acute Effects of Mat Pilates on Blood Pressure Response to Mental Stress in Higher Education Teachers
Behavior
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.
Kamran Yusuf, Ph.D. principal investigator
University of Calgary - Department of Pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Boppli Infant Blood Pressure Monitor in people with Blood Pressure, run by PyrAmes Inc. 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 7 inclusion and 3 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 22 Mar 2023. 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?
Assess the accuracy and precision of the Boppli System in continuous blood pressure monitoring (time frame: 6 - 72 Hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Mar 2023.