CareTaker Self-Calibration Validation

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02831777

Acronym

Self_Cal

Enrollment

140

Registered

2016-07-13

Start date

2016-03-31

Completion date

2016-05-31

Last updated

2016-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure

Keywords

non-invasive blood pressure

Brief summary

The goal of the study is to test the capability of the CareTaker monitor to calibrate its continuous blood pressure readings independently. Currently the device requires another approved blood pressure monitor to provide a starting calibration. The new control module enables the CareTaker to perform a pressure sweep of the internal pressure in the finger cuff. The resulting data is analyzed using a combination of pulse analysis/oscillometry approach.

Detailed description

The specific objective of this project was to demonstrate the CareTaker's ability to perform self-calibration to the same performance standard as its predicate device. That device demonstrated efficacy by showing substantial equivalence to the performance of classical sphygmomanometry using a Riva-Rocci/Korotkoff (RRK) measurement on the brachial artery, meeting a bias of at least 5 mmHg and a standard deviation of 8 mmHg across 3 paired readings from at least 85 patients, for a total of at least 255 paired readings. The study was performed at the University of Virginia Medical Center in Charlottesville, Virginia. UVA's Institutional Review Board approved (#18686) and supervised the study for subjects who were University of Virginia hospital patients and staff \> 18 years of age and who were able to give verbal consent.

Interventions

DEVICEnon-invasive blood pressure monitor

Equivalence of CareTaker blood pressure to classical sphygmomanometry

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* \> 18 years of age, who are able and willing to participate and have given verbal assent

Exclusion criteria

* Unable to give verbal assent * \<18 years of age * No or poor finger pulse, as determined through visual inspection for ischemic hands

Design outcomes

Primary

Measure	Time frame	Description
Performance comparison	8 minutes for 3 paired readings	Comparison with performance of classical sphygmomanometry using a Riva-Rocci/Korotkov (RRK) measurement on the brachial artery, meeting a bias of at least 5 mmHg and a standard deviation of 8 mmHg

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026