Status:
COMPLETED
Non-invasive Continuous Blood Pressure Monitoring
Lead Sponsor:
PyrAmes Inc.
Collaborating Sponsors:
University of Calgary
Conditions:
Blood Pressure
Eligibility:
All Genders
Up to 12 years
Phase:
NA
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 me...
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 hospi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 22 2022
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT05224011
Start Date
June 22 2022
End Date
September 22 2022
Last Update
March 22 2023
Active Locations (1)
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1
Foothills Medical Center Neonatal Intensive Care Unit, NICU 51
Calgary, Alberta, Canada, T2N 4N1