CareTaker PDA Device for High Blood Pressure in Children
Recruiting in Palo Alto (17 mi)
Overseen byKaren Boretsky, MD
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Boston Children's Hospital
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
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.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
I have chosen not to participate in this trial.
I have heart disease that affects my arteries.
Participant Groups
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.
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 Clinic Near You
Research Locations NearbySelect from list below to view details:
Boston Children's HopsitalBoston, MA
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Who Is Running the Clinical Trial?
Boston Children's HospitalLead Sponsor
CareTaker Medical LLCIndustry Sponsor