Caretaker vs. Routine Blood Pressure Sphygmomanometer

November 11, 2021 updated by: The Cooper Health System
Caretaker vs. routine blood pressure sphygmomanometer

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to: Compare blood pressure obtained using routine blood pressure sphygmomanometer to a non-invasive device that continuously monitors central blood pressure (CareTaker).

Study Type

Observational

Enrollment (Actual)

170

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults ages > 18 who are having their blood pressure monitored using routine blood pressure sphygmomanometer.

Description

Inclusion Criteria:

  • Adults ages > 18 who are having their blood pressure monitored using routine blood pressure sphygmomanometer.

Exclusion Criteria:

  • Patients not scheduled to be monitored using blood pressure sphygmomanometer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Caretaker
Comparing blood pressure obtained using routine blood pressure sphygmomanometer to a non-invasive device that continuously monitors central blood pressure (CareTaker).
Device: Caretaker
Application of Caretaker device to subjects that are scheduled for elective surgeries.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparing blood pressure using routine blood pressure cuff to that recorded by the Caretaker device.
Time Frame: Length of surgery
As per blood pressure monitor validation guidelines, the primary outcome measure will be the average difference in systolic and diastolic blood pressure measurements between the investigational device (Caretaker) and the reference (brachial cuff). In line with the ANSI/ISO/AAMI guidelines, we will obtain multiple investigational-reference measurement pairs in each subject (every 5 minutes during the surgical case) and will average the difference over all pairs from all subjects.
Length of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cooper Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2017

Primary Completion (Actual)

November 9, 2021

Study Completion (Actual)

November 10, 2021

Study Registration Dates

First Submitted

October 10, 2018

First Submitted That Met QC Criteria

April 16, 2019

First Posted (Actual)

April 17, 2019

Study Record Updates

Last Update Posted (Actual)

November 12, 2021

Last Update Submitted That Met QC Criteria

November 11, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 17-119EX

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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