Clinical trial NCT04817137: Validation of a Novel Non-invasive Continuous Blood Pressure Monitor in Children Ages 2- 17 Years-old
Official title: Validation of a Novel Non-invasive Continuous Blood Pressure Monitor in Children Ages 2- 17 Years-old
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Blood Pressure
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: CareTaker Medical LLC
First posted: 2021-03-26
Enrollment: 35
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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:

* Patients with vascular or congenital heart disease known to affect large and small arteries
* Patients who declined to participate.

Primary outcomes:
measure: Blood Pressure Comparison
timeFrame: One hour during procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hopsital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Karen Boretsky, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: The Handbook of Cuffless Blood Pressure Monitoring. Edited by J Sola, Delgado-Gonzalo R, 2019 Springer Nature Swirtzerland AG 2019.
citation: Heeney ND, Habib F, Brar GK, Krahn G, Campbell DA, Sanatani S, Claydon VE. Validation of finger blood pressure monitoring in children. Blood Press Monit. 2019 Jun;24(3):137-145. doi: 10.1097/MBP.0000000000000374.
citation: Epstein S, Willemet M, Chowienczyk PJ, Alastruey J. Reducing the number of parameters in 1D arterial blood flow modeling: less is more for patient-specific simulations. Am J Physiol Heart Circ Physiol. 2015 Jul 1;309(1):H222-34. doi: 10.1152/ajpheart.00857.2014. Epub 2015 Apr 17.