Data Collection of BP Values by CS6BP

NCT04215185 | Unknown

• 1 other identifier: 004_BPI_DC_OS
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (1)

Blood pressure monitor

EXPERIMENTAL

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

Interventions

Arterial LIne DEVICE

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.

Also known as: A-Line

Blood pressure monitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• CardiacSense Ltd.: lead

Study Sites (1)

Sourasky Medical Center

Tel Aviv, 62431, Israel

RECRUITING

MeSH Terms

Interventions

Vascular Access Devices

Intervention Hierarchy (Ancestors)

Catheters; Equipment and Supplies

Study Officials

• Adi Nimrod, MD

  Director Intensive Care Unit, Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benita Lanzer

CONTACT

972546861500; benita.lanzer@ocardiacsense.com

Liat Shemesh

CONTACT

liat.shemesh@cardiacsense.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Non-anaesthetized subjects in the ICU (Intensive Care Unit) or in the CICU (Cardiac Intensive Care Unit) with arterial line placement in the radial artery.

Study Record Dates

• First Submitted: December 23, 2019
• First Posted: January 2, 2020
• Study Start: July 3, 2020
• Primary Completion: June 15, 2022
• Study Completion: June 15, 2022
• Last Updated: January 19, 2022

Record last verified: 2022-01

Locations

IL (1)