Data Collection of BP Values by CS6BP

Blood Pressure Clinical Trial

— BPI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04215185
• Other study ID #: 004_BPI_DC_OS
• Status: Recruiting
• Phase: N/A
• Start date: July 3, 2020
• Est. completion date: June 15, 2022

Study information

• Verified date: January 2022
• Source: CardiacSense Ltd.
• Contact: Benita Lanzer
• Phone: 972546861500
• Email: benita.lanzer[@]ocardiacsense.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 15, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Blood Pressure

Intervention

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.

Locations

Country	Name	City	State
Israel	Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
CardiacSense Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)