Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06513975
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Validation Study of CART BP as a Wearable Cuffless Blood Pressure Monitor
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Validation Study of CART BP as a Wearable Cuffless Blood Pressure Monitor Evaluation of Blood Pressure Measurement by Height and Physical Activity
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to evaluate the accuracy of the CART BP a medically approved ring-type blood pressure monitor in comparison to the traditional auscultatory method using a dual-head stethoscope The comparison is conducted in accordance with the 2023 European Society of Hypertension ESH Recommendations focusing on patients with suspected hypertension or hypotension The evaluation includes accuracy measurements across various postures and during different exercise periods
Detailed Description:
There is a non-invasive technique called Photoplethysmography PPG that overcomes the limitations of traditional auscultatory and oscillometric methods Photoplethysmography uses light-emitting diodes LEDs to illuminate human tissue specifically targeting blood vessels and employs sensors to measure the volume of blood flowing through the tissue This technique can be applied to various parts of the small arterial system in the human body enabling cuffless blood pressure measurement As a result it simplifies blood pressure monitoring for subjects and allows for extended observation periods
With the advancement of cuffless blood pressure monitors the European Society of Hypertension ESH has established recommendations to ensure accurate measurements The recommendations consider variations in measurement height and compare accuracy after blood pressure is elevated through aerobic exercise or low-intensity repetitive exercises such as handgrip exercises This study aims to follow the 2023 European Society of Hypertension recommendations by measuring blood pressure with the arm positioned vertically more than 20 centimeters below the standard position and comparing the results obtained after repeated handgrip exercises with those obtained using the standard method
With the advancement of cuffless blood pressure monitors the European Society of Hypertension ESH has established recommendations to ensure accurate measurements The recommendations consider variations in measurement height and compare accuracy after blood pressure is elevated through aerobic exercise or low-intensity repetitive exercises such as handgrip exercises This study aims to follow the 2023 European Society of Hypertension recommendations by measuring blood pressure with the arm positioned vertically more than 20 centimeters below the standard position and comparing the results obtained after repeated handgrip exercises with those obtained using the standard method
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None