NCT04215185

Data Collection of BP Values by CS6BP

Prospective Open Study for the Development of CS6BP Continuous, Absolute, Non-Inflating Measurement of Blood Pressure

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: CardiacSense Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this research is to collect data to develop an algorithm for continuous, non-inflating measurement of absolute, long-term Blood Pressure using the CS6BP device and to evaluate the safety of the CS6BP.

Detailed description

The study will take place in the ICU (Intensive Care Unit) on non-anesthetized subjects with an arterial line inserted into the radial artery. The CS6BP non-invasive continuous recording will be collected parallel to an invasive arterial line recording. ECG data that was recorded in the ICU will be collected as well. The study will include up to 80 subjects. The subject may be measured by the CS6BP device more than once to check reproducibility. The first measurement may take up to 24h; Subsequent measurements may take up to 5h. All the data analysis will be done offline.

Conditions

• Blood Pressure

Interventions

Type	Name	Description
DEVICE	Arterial LIne	Continuous non-invasive recording of CS6BP will be taken parallel to the recording of an invasive arterial line. ECG data recorded in the ICU will also be collected.

Timeline

• Start date: 2020-07-03
• Primary completion: 2022-06-15
• Completion: 2022-06-15
• First posted: 2020-01-02
• Last updated: 2022-01-19

Locations

1 site across 1 country: Israel