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Recruiting NCT04071015

NCT04071015 Comparison of Non-Invasive Blood Pressure (NIBP) Using the Biobeat Device with an Invasive Arterial Line Catheter

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Clinical Trial Summary
NCT ID NCT04071015
Status Recruiting
Phase
Sponsor Biobeat Technologies Ltd.
Condition Blood Pressure
Study Type OBSERVATIONAL
Enrollment 250 participants
Start Date 2020-06-15
Primary Completion 2026-11

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type OBSERVATIONAL
Interventions
Non-invasive monitoring

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 250 participants in total. It began in 2020-06-15 with a primary completion date of 2026-11.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

In this clinical study the investigators will compare blood pressure measurements obtained using the non-invasive, wireless Biobeat monitoring device (both a wrist watch and a patch configuration) to an invasive arterial line catheter (radial or femoral) and a Swan Ganz Catheter in 20 patients immediately after cardiac surgery, at the cardiac intensive care unit.

Eligibility Criteria

Inclusion Criteria: * 18 years old and above patients of both sexes arriving immediately after cardiac surgery to the intensive care unit with a radial/femoral arterial line and or a Swan Ganz catheter and in need for blood pressure monitoring. Exclusion Criteria: * Refusal to participate * Patients with no need or no technical capability to have an arterial line * Pregnant women * Individuals under the age of 18 years * Patients with lack of judgment/mental illness * Patients working in the Sheba Medical Center

Contact & Investigator

Central Contact

Arik Eisenkraft, MD, MHA

✉ dr.arik@bio-beat.gov

📞 +972-52-9210896

Principal Investigator

Erez Kachel, MD

PRINCIPAL INVESTIGATOR

The Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel

Frequently Asked Questions

Who can join the NCT04071015 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Blood Pressure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT04071015 currently recruiting?

Yes, NCT04071015 is actively recruiting participants. Contact the research team at dr.arik@bio-beat.gov for enrollment information.

Where is the NCT04071015 trial being conducted?

This trial is being conducted at Ramat Gan, Israel.

Who is sponsoring the NCT04071015 clinical trial?

NCT04071015 is sponsored by Biobeat Technologies Ltd.. The principal investigator is Erez Kachel, MD at The Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel. The trial plans to enroll 250 participants.

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