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Caretaker vs. Routine Blood Pressure Sphygmomanometer

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ClinicalTrials.gov Identifier: NCT03918486
Recruitment Status : Recruiting
First Posted : April 17, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
The Cooper Health System

Brief Summary:
Caretaker vs. routine blood pressure sphygmomanometer

Condition or disease Intervention/treatment
Blood Pressure Device: Caretaker

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).

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Caretaker vs. Routine Blood Pressure Sphygmomanometer
Actual Study Start Date : September 5, 2017
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

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.




Primary Outcome Measures :
  1. 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.



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:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults ages > 18 who are having their blood pressure monitored using routine blood pressure sphygmomanometer.
Criteria

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.

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): NCT03918486


Contacts
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Contact: Irwin Gratz, MD 856-342-2000 gratz-irwin@cooperhealth.edu

Locations
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United States, New Jersey
Cooper University Hospital Recruiting
Camden, New Jersey, United States, 08103
Contact: Irwin Gratz, MD    856-342-2000    gratz-irwin@cooperhealth.edu   
Sponsors and Collaborators
The Cooper Health System

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Responsible Party: The Cooper Health System
ClinicalTrials.gov Identifier: NCT03918486     History of Changes
Other Study ID Numbers: 17-119EX
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No