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Non-invasive Continuous Blood Pressure Monitoring

NCT05224011 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2023-03-22

No results posted yet for this study

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

Interventions

DEVICE

Boppli Infant Blood Pressure Monitor

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

Sponsors & Collaborators

  • University of Calgary

    collaborator OTHER

  • PyrAmes Inc.

    lead INDUSTRY

Principal Investigators

  • Kamran Yusuf, Ph.D. · University of Calgary - Department of Pediatrics

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
12 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-22
Primary Completion
2022-09-22
Completion
2022-09-22

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05224011 on ClinicalTrials.gov