Data Collection of BP Values by CS6BP (BPI)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Blood Pressure
• Intervention / Treatment: Device: Arterial LIne

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Benita Lanzer; Phone Number: 972546861500; Email: benita.lanzer@ocardiacsense.com
• Study Contact Backup: Name: Liat Shemesh; Email: liat.shemesh@cardiacsense.com

Study Locations

• Israel
  • Tel Aviv, Israel, 62431
    • Recruiting
    • Sourasky Medical Center
    • Contact: Adi Nimrod, MD; Phone Number: 0524266719; Email: nimroda@tlvmc.gov.il
    • Principal Investigator: Adi Nimrod, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blood pressure monitor; 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.	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.; Other Names: A-Line

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: CardiacSense Ltd.
• Investigators: Principal Investigator: Adi Nimrod, MD, Director Intensive Care Unit, Tel-Aviv Sourasky Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2020
• Primary Completion (Anticipated): June 15, 2022
• Study Completion (Anticipated): June 15, 2022

Study Registration Dates

• First Submitted: December 23, 2019
• First Submitted That Met QC Criteria: December 31, 2019
• First Posted (Actual): January 2, 2020

Study Record Updates

• Last Update Posted (Actual): January 19, 2022
• Last Update Submitted That Met QC Criteria: January 4, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 004_BPI_DC_OS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No