NCT02831777

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 13, 2016

Completed
Last Updated

July 13, 2016

Status Verified

July 1, 2016

Enrollment Period

2 months

First QC Date

July 11, 2016

Last Update Submit

July 11, 2016

Conditions

Blood Pressure

Keywords

non-invasive blood pressure

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

non-invasive blood pressure monitorDEVICE

Equivalence of CareTaker blood pressure to classical sphygmomanometry

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Martin C Baruch, PhD

    CareTaker Medical LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2016

First Posted

July 13, 2016

Study Start

March 1, 2016

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

July 13, 2016

Record last verified: 2016-07