Validation of a Novel Non-invasive Continuous Blood Pressure Monitor in Children Ages 2- 17 Years-old
NCT ID: NCT04817137
Last Updated: 2023-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
35 participants
INTERVENTIONAL
2021-05-14
2024-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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All Enrolled Patients
Patients will wear the Caretaker Pulse Decomposition Analysis (PDA) Device, which will record the patient's blood pressure.
CareTaker PDA Device
Non-invasive blood pressure monitoring
Interventions
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CareTaker PDA Device
Non-invasive blood pressure monitoring
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients who declined to participate.
2 Years
17 Years
ALL
No
Sponsors
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CareTaker Medical LLC
INDUSTRY
Boston Children's Hospital
OTHER
Responsible Party
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Karen Boretsky
Anesthesiologist
Principal Investigators
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Karen Boretsky, MD
Role: PRINCIPAL_INVESTIGATOR
Boston Children's Hospital
Locations
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Boston Children's Hopsital
Boston, Massachusetts, United States
Countries
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References
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Scheer B, Perel A, Pfeiffer UJ. Clinical review: complications and risk factors of peripheral arterial catheters used for haemodynamic monitoring in anaesthesia and intensive care medicine. Crit Care. 2002 Jun;6(3):199-204. doi: 10.1186/cc1489. Epub 2002 Apr 18.
Gratz I, Deal E, Spitz F, Baruch M, Allen IE, Seaman JE, Pukenas E, Jean S. Continuous Non-invasive finger cuff CareTaker(R) comparable to invasive intra-arterial pressure in patients undergoing major intra-abdominal surgery. BMC Anesthesiol. 2017 Mar 21;17(1):48. doi: 10.1186/s12871-017-0337-z.
Baruch MC, Kalantari K, Gerdt DW, Adkins CM. Validation of the pulse decomposition analysis algorithm using central arterial blood pressure. Biomed Eng Online. 2014 Jul 8;13:96. doi: 10.1186/1475-925X-13-96.
Phillips AA, Burr J, Cote AT, Foulds HJ, Charlesworth S, Bredin SS, Warburton DE. Comparing the Finapres and Caretaker systems for measuring pulse transit time before and after exercise. Int J Sports Med. 2012 Feb;33(2):130-6. doi: 10.1055/s-0031-1291185. Epub 2011 Nov 17.
The Handbook of Cuffless Blood Pressure Monitoring. Edited by J Sola, Delgado-Gonzalo R, 2019 Springer Nature Swirtzerland AG 2019.
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.
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.
Boretsky KR, Nasr VG, Atkinson D, Baruch M. Comparison of continuous non-invasive blood pressure measurement using Vitalstream to invasive Intraarterial pressure in pediatric surgery. J Clin Anesth. 2025 Mar;102:111763. doi: 10.1016/j.jclinane.2025.111763. Epub 2025 Jan 23.
Other Identifiers
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IRB-P00037138
Identifier Type: -
Identifier Source: org_study_id
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