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OpenTrials
Completed

NCT Number: NCT03918486

Caretaker vs. Routine Blood Pressure Sphygmomanometer

Caretaker vs. routine blood pressure sphygmomanometer

Completed

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Key information

Conditions

Blood Pressure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cooper University Hospital

Camden, New Jersey, 08103, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Caretaker

Device

Application of Caretaker device to subjects that are scheduled for elective surgeries.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

The Cooper Health System

Other

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Apr 17, 2019
Registry last updated
Nov 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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