Validation of a Novel Non-invasive Continuous Blood Pressure Monitor in Children Ages 2- 17 Years-old
- Conditions
- Blood Pressure
- Interventions
- Device: CareTaker PDA Device
- Registration Number
- NCT04817137
- Lead Sponsor
- Boston Children's Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 35
- Plan to receive an invasive arterial blood pressure monitor as part of their anesthesia care plan at the BCH Longwood campus
- Patients with vascular or congenital heart disease known to affect large and small arteries
- Patients who declined to participate.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description All Enrolled Patients CareTaker PDA Device Patients will wear the Caretaker Pulse Decomposition Analysis (PDA) Device, which will record the patient's blood pressure.
- Primary Outcome Measures
Name Time Method Blood Pressure Comparison 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Boston Children's Hopsital
🇺🇸Boston, Massachusetts, United States