Data Collection of BP Values by CS6BP (BPI)

CardiacSense

Status: Unknown

Conditions: Blood Pressure

Treatments: Device: Arterial LIne

Study type: Interventional

Funder types: Industry

Identifiers

NCT04215185

004_BPI_DC_OS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age of eighteen (18) year and above
• Ability and willingness to sign an informed consent form
• Monitored by radial arterial line

Exclusion criteria

• Subjects with hemodynamic support
• Subjects receiving more than 2-3 l of fluid per 24h
• Subjects with septic shock
• Subjects with distal edema
• Subjects with arms trauma, where the watch is not wearable
• Subjects where the radial artery could not be palpate
• Subjects with life expectancy of less than 24h.
• Subjects who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the subject's participation in this study
• Any concomitant condition which, in the opinion of the investigator, would not allow safe participation in the study (e.g. drug addiction, alcohol abuse, emotional/psychological diagnosis)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Blood pressure monitor

Experimental group

Description:

The CS6BP device will be placed on non-anesthetized subjects in the ICU (Intensive Care Unit) with arterial line placement in the radial artery. The first measurement will be for up to 24h; subsequent measures will be up to 5h.

Treatment:

Device: Arterial LIne