Data Collection of BP Values by CS6BP

Not Applicable

• Conditions: Blood Pressure
• Interventions: Device: Arterial LIne

• Registration Number: NCT04215185
• Lead Sponsor: CardiacSense Ltd.

Brief 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.

Study Timeline

• Study First Submitted: 2019-12-23
• Study First Submitted QC: 2019-12-31
• Study First Posted: 2020-01-02
• Study Start: 2020-07-03
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-04
• Last Update Posted: 2022-01-19
• Primary Completion: 2022-06-15
• Study Completion: 2022-06-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blood pressure monitor	Arterial LIne	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.

Primary Outcome Measures

Name	Time	Method
Safety of CardiacSense 1BP: Incidence and severity of device related Adverse Events	measurement time (up to 24 hours)	Incidence and severity of device related Adverse Events
Collection of data from CardicacSense1BP measurements for algorithm development	measurement time (up to 24 hours)	CardicacSense1BP data will be collected in parallel with blood pressure data from ICU a- line .

Trial Locations

Locations (1)

Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel