Caretaker vs. Routine Blood Pressure Sphygmomanometer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03918486|
Recruitment Status : Recruiting
First Posted : April 17, 2019
Last Update Posted : July 8, 2019
|Condition or disease||Intervention/treatment|
|Blood Pressure||Device: Caretaker|
|Study Type :||Observational|
|Estimated Enrollment :||120 participants|
|Official Title:||Caretaker vs. Routine Blood Pressure Sphygmomanometer|
|Actual Study Start Date :||September 5, 2017|
|Estimated Primary Completion Date :||December 30, 2019|
|Estimated Study Completion Date :||December 30, 2019|
Comparing blood pressure obtained using routine blood pressure sphygmomanometer to a non-invasive device that continuously monitors central blood pressure (CareTaker).
Application of Caretaker device to subjects that are scheduled for elective surgeries.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03918486
|Contact: Irwin Gratz, MDemail@example.com|
|United States, New Jersey|
|Cooper University Hospital||Recruiting|
|Camden, New Jersey, United States, 08103|
|Contact: Irwin Gratz, MD 856-342-2000 firstname.lastname@example.org|