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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one hour during procedure
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Blood Pressure Comparison

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
756 Previous Clinical Trials
5,579,184 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
80 Total Patients Enrolled

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants aged less than fifty years old allowed to join this research effort?

"Patients of any age between 2 and 17 years old are eligible for inclusion in this research."

Answered by AI

What is the current sample size for this experiment?

"Affirmative. Clinicaltrials.gov data reveals that this trial, which has been active since May 14th 2021, is still seeking patients to enrol in the study. 30 individuals will be accepted at a single medical centre."

Answered by AI

Are there any openings in this clinical trial currently?

"Affirmative. According to the information found on clinicaltrials.gov, this study is actively recruiting subjects and was first posted on May 14th 2021 before being updated most recently on June 7th 2021. A total of 30 patients need to be recruited from 1 site."

Answered by AI

Is participation in this research study feasible for me?

"This trial accepts 30 participants in the age range of 2 to 17 with normal blood pressure."

Answered by AI
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~9 spots leftby Mar 2025