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OpenTrials
Completed

NCT Number: NCT02831777

CareTaker Self-Calibration Validation

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.

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Key information

Conditions

Blood Pressure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

non-invasive blood pressure monitor

Device

Equivalence of CareTaker blood pressure to classical sphygmomanometry

Primary outcomes

  1. Performance comparison

    Time frame: 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

Sponsors and collaborators

Lead sponsor

CareTaker Medical LLC

Industry

Collaborators

  • University of Virginia

Registry information

Acronym: Self_Cal

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 13, 2016
Registry last updated
Jul 13, 2016

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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