Ignite Creation Date:
2024-05-06 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05224011
Status:
COMPLETED
Last Update Posted:
2023-03-22
First Post:
2022-01-04
Brief Title:
Non-invasive Continuous Blood Pressure Monitoring
Sponsor:
PyrAmes Inc
Organization:
PyrAmes Inc
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 patients 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 PyrAmess 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 neonatesinfants 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 subjects medical record
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 neonatesinfants 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 subjects medical record
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None