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OpenTrials
Completed

NCT Number: NCT04817137

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

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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Key information

Conditions

Blood Pressure

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Children's Hopsital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CareTaker PDA Device

Device

Non-invasive blood pressure monitoring

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • CareTaker Medical LLC

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 26, 2021
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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