CareTaker Self-Calibration Validation

NCT ID: NCT02831777

Last Updated: 2016-07-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 140 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2016-05-31

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.

Conditions

Blood Pressure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

non-invasive blood pressure monitor

Equivalence of CareTaker blood pressure to classical sphygmomanometry

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Virginia

OTHER

Sponsor Role: collaborator

CareTaker Medical LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin C Baruch, PhD

Role: PRINCIPAL_INVESTIGATOR

CareTaker Medical LLC

Other Identifiers

SELF_CAL_001

Identifier Type: -

Identifier Source: org_study_id