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Caretaker vs. Routine Blood Pressure Sphygmomanometer

Completed
Conditions
Blood Pressure
Interventions
Device: Caretaker
Registration Number
NCT03918486
Lead Sponsor
The Cooper Health System
Brief Summary

Caretaker vs. routine blood pressure sphygmomanometer

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).

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
170
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
CaretakerCaretakerComparing blood pressure obtained using routine blood pressure sphygmomanometer to a non-invasive device that continuously monitors central blood pressure (CareTaker).
Primary Outcome Measures
NameTimeMethod
Comparing blood pressure using routine blood pressure cuff to that recorded by the Caretaker device.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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Cooper University Hospital

🇺🇸

Camden, New Jersey, United States

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