Non-invasive Continuous Blood Pressure Monitoring

NCT05224011 | Completed

• 1 other identifier: PyrAmes-2021-01
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Blood Pressure

Keywords

Neonates; Blood Pressure monitoring; Medical Device; Non-Invasive Blood Pressure Monitoring; Invasive Arterial Lines

Outcome Measures

Primary Outcomes (1)

• 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

  6 - 72 Hours

Secondary Outcomes (1)

• Assess the safety of the Boppli System in a clinical setting

  6 - 72 Hours

Study Arms (1)

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.

Device: Boppli Infant Blood Pressure Monitor

Interventions

Boppli Infant Blood Pressure Monitor DEVICE

The intervention is a medical device for the non-invasive measurement of blood pressure in infants

Experimental

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PyrAmes Inc.: lead
• University of Calgary: collaborator

Study Sites (1)

Foothills Medical Center Neonatal Intensive Care Unit, NICU 51

Calgary, Alberta, T2N 4N1, Canada

Location

Study Officials

• Kamran Yusuf, Ph.D.

  University of Calgary - Department of Pediatrics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: February 4, 2022
• Study Start: June 22, 2022
• Primary Completion: September 22, 2022
• Study Completion: September 22, 2022
• Last Updated: March 22, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)