Caretaker vs. Routine Blood Pressure Sphygmomanometer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03918486

Enrollment

170

Registered

2019-04-17

Start date

2017-09-05

Completion date

2021-11-10

Last updated

2021-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure

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).

Interventions

DEVICECaretaker

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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026