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CareTaker Self-Calibration Validation (Self_Cal)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02831777
Recruitment Status : Completed
First Posted : July 13, 2016
Last Update Posted : July 13, 2016
Sponsor:
Collaborator:
University of Virginia
Information provided by (Responsible Party):
CareTaker Medical LLC

Study Description
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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.


Condition or disease Intervention/treatment
Blood Pressure Device: non-invasive blood pressure monitor

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.

Study Design
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Study Type : Observational
Actual Enrollment : 140 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: CareTaker Self-Calibration Validation
Study Start Date : March 2016
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016
Groups and Cohorts
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Intervention Details:
  • Device: non-invasive blood pressure monitor
    Equivalence of CareTaker blood pressure to classical sphygmomanometry

Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Subjects will be UVA patients/staff, > 18 years of age, who are able and willing to participate and have given verbal assent
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02831777


Sponsors and Collaborators
CareTaker Medical LLC
University of Virginia
Investigators
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Principal Investigator: Martin C Baruch, PhD CareTaker Medical LLC
More Information
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Responsible Party: CareTaker Medical LLC
ClinicalTrials.gov Identifier: NCT02831777    
Other Study ID Numbers: SELF_CAL_001
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: July 13, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by CareTaker Medical LLC:
non-invasive blood pressure