CareTaker Self-Calibration Validation

Blood Pressure Clinical Trial

— Self_Cal  

Official title:

CareTaker Self-Calibration Validation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02831777
• Other study ID #: SELF_CAL_001
• Status: Completed
• Phase: N/A
• First received: July 11, 2016
• Last updated: July 11, 2016
• Start date: March 2016
• Est. completion date: May 2016

Study information

• Verified date: July 2016
• Source: CareTaker Medical LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Device:
• non-invasive blood pressure monitor
Equivalence of CareTaker blood pressure to classical sphygmomanometry

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
CareTaker Medical LLC	University of Virginia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance comparison	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	8 minutes for 3 paired readings	No