- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05224011
Non-invasive Continuous Blood Pressure Monitoring
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Pamela Ovadje, Ph.D.
- Phone Number: 1(403) 210-8436
- Email: impact@ucalgary.ca
Study Locations
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Alberta
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Calgary, Alberta, Canada, T2N 4N1
- Foothills Medical Center Neonatal Intensive Care Unit, NICU 51
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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The intervention is a medical device for the non-invasive measurement of blood pressure in infants
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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:
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6 - 72 Hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assess the safety of the Boppli System in a clinical setting
Time Frame: 6 - 72 Hours
|
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:
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6 - 72 Hours
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kamran Yusuf, Ph.D., University of Calgary - Department of Pediatrics
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PyrAmes-2021-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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