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Clinical Trials/NCT04817137
NCT04817137
Completed
N/A

Validation of a Novel Non-invasive Continuous Blood Pressure Monitor in Children Ages 2- 17 Years-old

Boston Children's Hospital2 sites in 1 country35 target enrollmentMay 14, 2021
ConditionsBlood Pressure

Overview

Phase
N/A
Intervention
CareTaker PDA Device
Conditions
Blood Pressure
Sponsor
Boston Children's Hospital
Enrollment
35
Locations
2
Primary Endpoint
Blood Pressure Comparison
Status
Completed
Last Updated
23 days ago

Overview

Brief Summary

This is a prospective observational study to investigate if a non-invasive blood pressure monitoring device, the CareTaker Pulse Decomposition Analysis (PDA), can accurately measure blood pressure in children when compared to an arterial line. Enrolled patients will have the CareTaker PDA device placed on their finger during their operation to collect data for 30 minutes. Blood pressure readings from the CareTaker PDA device will be compared to measurements from the patient's indwelling arterial line, which will be placed as part of the patient's clinical care plan.

Registry
clinicaltrials.gov
Start Date
May 14, 2021
End Date
July 21, 2023
Last Updated
23 days ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Karen Boretsky

Anesthesiologist

Boston Children's Hospital

Eligibility Criteria

Inclusion Criteria

  • Plan to receive an invasive arterial blood pressure monitor as part of their anesthesia care plan at the BCH Longwood campus

Exclusion Criteria

  • Patients with vascular or congenital heart disease known to affect large and small arteries
  • Patients who declined to participate.

Arms & Interventions

All Enrolled Patients

Patients will wear the Caretaker Pulse Decomposition Analysis (PDA) Device, which will record the patient's blood pressure.

Intervention: CareTaker PDA Device

Outcomes

Primary Outcomes

Blood Pressure Comparison

Time Frame: One hour during procedure

The accuracy of blood pressure measurements taken from the non-invasive blood pressure device will be compared to measurements taken from the patient's indwelling arterial line, which will be place as part of standard of care.

Study Sites (2)

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