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BoppliTM blood pressure monitoring

A Prospective Study to Evaluate the Safety and Effectiveness of the BoppliTM in Measuring Mean Arterial Pressure (MAP), Systolic Blood Pressure (SBP), and Diastolic Blood Pressure (DBP) as Compared to an Invasive Arterial Reference

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Neonatal care
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All genders
person-wave 0-18
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Overview

Principal Investigator: Rodica Turcu, MD

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. This study will evaluate the accuracy and precision of the Boppli system for continuous blood pressure monitoring by comparing SBP, DBP, and MAP against the reference methodology in pediatric and neonatal populations.

Primary Effectiveness Endpoint: Mean and standard deviation of the difference of the paired measurements between the device and arterial line reference for systolic, diastolic and mean pressures treated separately.

Safety endpoint: Device related adverse events

To assess the accuracy of the test device, a mean average difference of +/- 5 mmHg with a standard deviation of 8 mmHg of difference between the test device and the intra-arterial reference method will be considered as the upper limits of clinically acceptable disagreement. These parameters are in accordance with ISO 81060-2 and ANSI/AAMI SP10 for neonatal/infant populations using an intra-arterial method as the reference standard.

In addition to the test of accuracy, the stability test will be used to assess the accuracy over the duration of use of the device.

The change test will be used to demonstrate that the Boppli device will measure clinically relevant changes in BP measurements.

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Rodica Turcu, MD

Study details

Inclusion Criteria
  • Inclusion criteria for Groups 1-4:
    - Pediatric patients less than 1 year of age and less than 5,000 g in weight (primary target)
    - Require intra-arterial blood pressure monitoring
  • Inclusion criteria for Group 5:
    - Pediatric patients
    - Require intra-arterial blood pressure monitoring
    Note: Under no circumstances 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 Requirements

The following steps will be performed specifically to collect data for this study:

  • Boppli devices supplied by PyrAmes will be used alongside IALs used onsite to collect blood pressure measurements, including systolic, diastolic, and mean arterial pressure measurements, as well as pulse waveforms. These devices will be approved by each site before use in the study.
  • Continuous data from the IAL and the Boppli device will be paired for comparison as described in the Statistical Analysis Plan (SAP).
  • The total duration of data collection is dependent on the time IAL blood pressure measurements are necessary to be obtained. The minimum duration 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 from the patient.
  • While it would not be ethical to induce rapid blood pressure changes in this patient population, observed rapid changes in blood pressure will be collected and the Boppli device’s accuracy in detecting these changes will be compared against IAL as described in SAP.
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