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CareTaker PDA Device for High Blood Pressure in Children

N/A
Waitlist Available
Led By Karen Boretsky, MD
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Must not have
Patients who declined to participate.
Patients with vascular or congenital heart disease known to affect large and small arteries
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one hour during procedure
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare readings from a non-invasive blood pressure monitor to those from an arterial line in children to see if the former is accurate.

Who is the study for?
This clinical trial is for children aged 2 to 17 who are scheduled to receive an arterial blood pressure monitor during anesthesia at the BCH Longwood campus. It's not suitable for kids with heart or vascular conditions that affect arteries, or those whose guardians have declined participation.
What is being tested?
The study is testing the CareTaker PDA Device, a non-invasive way to measure blood pressure using a finger cuff. It will be observed if this device can match the accuracy of traditional invasive arterial line measurements during surgery.
What are the potential side effects?
Since the CareTaker PDA Device is non-invasive and only worn on the finger, it's expected to have minimal side effects, primarily related to comfort and potential skin irritation from prolonged use.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have chosen not to participate in this trial.
Select...
I have heart disease that affects my arteries.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one hour during procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and one hour during procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Blood Pressure Comparison

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: All Enrolled PatientsExperimental Treatment1 Intervention
Patients will wear the Caretaker Pulse Decomposition Analysis (PDA) Device, which will record the patient's blood pressure.

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor
785 Previous Clinical Trials
5,581,696 Total Patients Enrolled
CareTaker Medical LLCIndustry Sponsor
5 Previous Clinical Trials
351 Total Patients Enrolled
Karen Boretsky, MDPrincipal Investigator - Boston Children's Hospital
Boston Children's Hospital, Dana-Farber Cancer Institute
University Of Pittsburgh School Of Medicine (Medical School)
1 Previous Clinical Trials

Media Library

All Enrolled Patients Clinical Trial Eligibility Overview. Trial Name: NCT04817137 — N/A
High Blood Pressure Research Study Groups: All Enrolled Patients
High Blood Pressure Clinical Trial 2023: All Enrolled Patients Highlights & Side Effects. Trial Name: NCT04817137 — N/A
All Enrolled Patients 2023 Treatment Timeline for Medical Study. Trial Name: NCT04817137 — N/A
~8 spots leftby Nov 2025
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