NCT04817137

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 26, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

May 14, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2023

Completed
Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

2.2 years

First QC Date

March 16, 2021

Last Update Submit

April 5, 2026

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

All Enrolled Patients

OTHER

Patients will wear the Caretaker Pulse Decomposition Analysis (PDA) Device, which will record the patient's blood pressure.

Device: CareTaker PDA Device

Interventions

CareTaker PDA DeviceDEVICE

Non-invasive blood pressure monitoring

All Enrolled Patients

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Plan to receive an invasive arterial blood pressure monitor as part of their anesthesia care plan at the BCH Longwood campus

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Children's Hopsital

Boston, Massachusetts, 02115, United States

Location

Related Publications (8)

  • 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.

    PMID: 12133178BACKGROUND

  • 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.

    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.

    PMID: 25005686BACKGROUND

  • 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.

    PMID: 22095319BACKGROUND

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

    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.

    PMID: 30840608BACKGROUND

  • 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.

    PMID: 25888513BACKGROUND

  • 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.

    PMID: 39854999DERIVED

Study Officials

  • Karen Boretsky, MD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

March 16, 2021

First Posted

March 26, 2021

Study Start

May 14, 2021

Primary Completion

July 21, 2023

Study Completion

July 21, 2023

Last Updated

April 9, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)