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NCT04817137 Clinical Trial

Validation of a Novel Non-invasive Continuous Blood Pressure Monitor in Children Ages 2- 17 Years-old

Blood Pressure Clinical Trial

Official title:
Validation of a Novel Non-invasive Continuous Blood Pressure Monitor in Children Ages 2- 17 Years-old

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04817137
Other study ID # IRB-P00037138
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 14, 2021
Est. completion date July 30, 2024

Study information
Verified date August 2023
Source Boston Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 35
Est. completion date July 30, 2024
Est. primary completion date July 21, 2023
Accepts healthy volunteers No
Gender All
Age group 2 Years to 17 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• CareTaker PDA Device
Non-invasive blood pressure monitoring

Locations
Country Name City State
United States Boston Children's Hopsital Boston Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
Boston Children's Hospital CareTaker Medical LLC

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. — View Citation

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. — View 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. — View Citation

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. — View Citation

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. — View Citation

The Handbook of Cuffless Blood Pressure Monitoring. Edited by J Sola, Delgado-Gonzalo R, 2019 Springer Nature Swirtzerland AG 2019.

Outcome
Type Measure Description Time frame Safety issue
Primary 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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