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| Name | Class |
|---|---|
| CareTaker Medical LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Enrolled Patients | Other | Patients will wear the Caretaker Pulse Decomposition Analysis (PDA) Device, which will record the patient's blood pressure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CareTaker PDA Device | Device | Non-invasive blood pressure monitoring |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure Comparison | 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. | One hour during procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Boretsky, MD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hopsital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12133178 | Background | 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. | |
| 28327093 | Background | 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. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 3, 2026 | May 28, 2026 | 6 | ||
| Jun 26, 2026 |
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| 25005686 | Background | 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. |
| 22095319 | Background | 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. |
| Background | The Handbook of Cuffless Blood Pressure Monitoring. Edited by J Sola, Delgado-Gonzalo R, 2019 Springer Nature Swirtzerland AG 2019. |
| 30840608 | Background | 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. |
| 25888513 | Background | 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. |
| 39854999 | Derived | 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. |