A Clinical Study to Validate the Accuracy of BTL-001-2 ABPM (Automated Non-Invasive Blood Pressure Sphygmomanometer) in Conformance with AAMI/ANSI/ BHS/ESH-IP/ISO81060-2:2013/ISO81060â??2:2018 & A1:2020

BTL India Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年6月26日

研究概览

暂无简介。

•1.Participants >= 3 years of age (minimum 30% male/female)
•2. Arm circumference between 12 cm - 44 cm.
•3. Willing to participate must be able to provide an informed consent or have legally authorized representative consent to participate.
•4.Participants who can tolerate sitting for up to 1 hour.

•1. Arm circumference less than 10 cm. or greater than 44 cm.
•2. Irregular heart rhythm (bigeminy, trigeminy, isolated ventricular premature beat (VPB), atrial fibrillation)
•3. Korotkoff sound K5 not audible.
•4. Musculoskeletal disorder that prevents a non-invasive device from being inflated/deflated on the arm.
•5. Unwilling to volunteer to participate and to sign the study specific informed consent form.
•6. Patients suffering with Parkinsonâ??s disease or other diseases with tremors.
•7. Patients with coagulation disturbances.
•8. Patients with serious mobility or other impairments without supervision.
•9. Subjects not ready to stay in hospital for up to 1 hour.

发起方

BTL India Pvt Ltd