NCT05105204

ArteVu Blood Pressure Accuracy Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Cardio Ring Technologies, Inc. Taiwan Branch · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

A continuous noninvasive blood pressure monitoring digital fingertip clip device, the ArteVu, will be compared against the reference arterial catheter during operation. The device safety and its blood pressure accuracy will be examined in the study.

Detailed description

ArteVu is a non-invasive and continuous blood pressure monitor. It detects the arterial pressure waveform with a force sensor that detects the arterial pulsation that produces changes in pressure transmitted through the subcutaneous tissue overlying or adjacent to the digital arteries. The data is transmitted to a parameter module to display noninvasive and continuous blood pressure in a hospital setting. The primary objective of this study is to validate ArteVu's blood pressure and heart rate measurement accuracy by comparing its values simultaneously with the corresponding values obtained from an invasive radial arterial line. The secondary objective is to evaluate the effectiveness of utilizing ArteVu for continuous blood pressure measurements. The study population includes 50 patients undergoing surgery who requires general anesthesia and continuous blood pressure measurement with a radial arterial line. Blood pressure values measured from the arterial line will be recorded simultaneously during ArteVu's measurements.

Conditions

• Blood Pressure

Interventions

Type	Name	Description
DEVICE	ArteVu	The study participants will concurrently undergo noninvasive blood pressure monitoring with the ArteVu finger clip applied to the same extremity that is being used to measure the radial artery pressure.

Timeline

• Start date: 2021-09-14
• Primary completion: 2022-03-01
• Completion: 2022-06-01
• First posted: 2021-11-03
• Last updated: 2021-11-03

Locations

1 site across 1 country: Taiwan