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NCT03918486 Clinical Trial

Caretaker vs. Routine Blood Pressure Sphygmomanometer

Blood Pressure Clinical Trial

Official title:
Caretaker vs. Routine Blood Pressure Sphygmomanometer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03918486
Other study ID # 17-119EX
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 5, 2017
Est. completion date November 10, 2021

Study information
Verified date November 2021
Source The Cooper Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Caretaker vs. routine blood pressure sphygmomanometer

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 information / eligibility
Status Completed
Enrollment 170
Est. completion date November 10, 2021
Est. primary completion date November 9, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Cooper University Hospital Camden New Jersey

Sponsors (1)
Lead Sponsor Collaborator
The Cooper Health System

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Comparing blood pressure using routine blood pressure cuff to that recorded by the Caretaker device. 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
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