Blood PressureNCT04817137

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

A study testing CareTaker PDA Device in people with Blood Pressure, run by Boston Children's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 2 to 17 years
Conditions the study is for: Blood Pressure
What is being tested?: CareTaker PDA Device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteUnited States
Study dates: 14 May 2021to 21 Jul 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Boston Children's Hopsital
Boston, Massachusetts, 02115

Other trials in United States

About this study

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.

Conditions: Blood Pressure
Being tested: CareTaker PDA Device

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CareTaker PDA DeviceDevice
Non-invasive blood pressure monitoring

Study groups in NCT04817137
Study group	Role	What they receive
All Enrolled Patients	Other	Patients will wear the Caretaker Pulse Decomposition Analysis (PDA) Device, which will record the patient's blood pressure. Receives: Device: CareTaker PDA Device

What is being measured

The primary outcome is the main question the study is designed to answer.

Blood Pressure Comparison (Systolic)
The accuracy of blood pressure measurements (systolic) 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.
Measured: One hour during procedure
Blood Pressure Comparison (Diastolic)
The accuracy of blood pressure measurements (diastolic) 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.
Measured: One hour during procedure
Blood Pressure Comparison (Mean)
The accuracy of blood pressure measurements (mean) 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.
Measured: One hour during procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 May 202121 Jul 2023

First posted26 Mar 2021
Study start14 May 2021
Primary completion21 Jul 2023
Study completion21 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Blood PressureStudies of the same condition, open and under way.
More trials run by Boston Children's HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04817137
Sponsor's protocol ID: IRB-P00037138
Status last verified: Apr 2026
First submitted: 16 Mar 2021
Last updated: 23 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 12133178
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.
PubMed 28327093
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.
PubMed 25005686
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.
PubMed 22095319
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.
PubMed 30840608
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.
PubMed 25888513
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.
PubMed 39854999

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Validation of a Novel Non-invasive Continuous Blood Pressure Monitor in Children Ages 2- 17 Years-old
ClinicalTrials.gov ID: NCT04817137
Acronym / sponsor ID: IRB-P00037138
Conditions: Blood Pressure
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Boston Children's HospitalUniversity, hospital or other
Collaborators: CareTaker Medical LLC
Study start: 14 May 2021 (actual)
Primary completion: 21 Jul 2023 (actual)
Study completion: 21 Jul 2023 (actual)
First posted: 26 Mar 2021 (actual)
Results: Posted 23 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
All Enrolled Patients	Other	Device: CareTaker PDA DevicePatients will wear the Caretaker Pulse Decomposition Analysis (PDA) Device, which will record the patient's blood pressure.

Who may qualify

Ages: 2 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CareTaker PDA DeviceNon-invasive blood pressure monitoring	Device	All Enrolled Patients

Primary outcome

Blood Pressure Comparison (Systolic)
Time frame: One hour during procedure
The accuracy of blood pressure measurements (systolic) 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.
Blood Pressure Comparison (Diastolic)
Time frame: One hour during procedure
The accuracy of blood pressure measurements (diastolic) 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.
Blood Pressure Comparison (Mean)
Time frame: One hour during procedure
The accuracy of blood pressure measurements (mean) 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.

Results and safety

Results posted to the registry on 23 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Enrolled Patients	35	31

Primary outcome: Blood Pressure Comparison (Systolic)

Time frame: One hour during procedure. Mean (Standard Deviation). Unit: mm Hg

Measure	All Enrolled Patients n = 31
Value	-3.79 (9.74)

Primary outcome: Blood Pressure Comparison (Diastolic)

Time frame: One hour during procedure. Mean (Standard Deviation). Unit: mm Hg

Measure	All Enrolled Patients n = 31
Value	1.72 (8.445)

Primary outcome: Blood Pressure Comparison (Mean)

Time frame: One hour during procedure. Mean (Standard Deviation). Unit: mm Hg

Measure	All Enrolled Patients n = 31
Value	2.41 (8.57)

Adverse events

Time frame: From enrollment to end of study, an average of 1 hour and 30 minutes. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Enrolled Patients	0 of 31 (0%)	0 of 31 (0%)	0 of 31

Limitations and caveats (from the sponsor): First, the sample size of 31 patients-although compliant with ISO standards-may not capture the full range of variability seen in larger, more diverse populations. Additionally, because no vasopressors were administered and none of the patients had significant central arterial pathology, the findings may not be generalizable to more complex clinical scenarios. The type of surgery was not standardized.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 12133178Scheer 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.
Background: PubMed 28327093Gratz 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: PubMed 25005686Baruch 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.
Background: PubMed 22095319Phillips 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.
BackgroundThe Handbook of Cuffless Blood Pressure Monitoring. Edited by J Sola, Delgado-Gonzalo R, 2019 Springer Nature Swirtzerland AG 2019.
Background: PubMed 30840608Heeney 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.
Background: PubMed 25888513Epstein 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.
Derived from this study: PubMed 39854999Boretsky 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Karen Boretsky, MD principal investigator

Boston Children's Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CareTaker PDA Device in people with Blood Pressure, run by Boston Children's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood Pressure Comparison (Systolic) (time frame: One hour during procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04817137, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.