Blood Pressure Clinical Trial
Official title:
Caretaker vs. Routine Blood Pressure Sphygmomanometer
Verified date | November 2021 |
Source | The Cooper Health System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Caretaker vs. routine blood pressure sphygmomanometer
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. |
Country | Name | City | State |
---|---|---|---|
United States | Cooper University Hospital | Camden | New Jersey |
Lead Sponsor | Collaborator |
---|---|
The Cooper Health System |
United States,
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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