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

NCT04817137 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-04-09

No results posted yet for this study

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.

Conditions

  • Blood Pressure

Interventions

DEVICE

CareTaker PDA Device

Non-invasive blood pressure monitoring

Sponsors & Collaborators

Principal Investigators

  • Karen Boretsky, MD · Boston Children's Hospital

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-14
Primary Completion
2023-07-21
Completion
2023-07-21
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT04817137 on ClinicalTrials.gov