Comparing non-invasive blood pressure monitoring with invasive methods after cardiac surgery
Official title: Comparison of Continuous Non-Invasive Blood Pressure Measurement Using the Wireless Cuffless Biobeat Monitor with an Invasive Arterial Line Catheter
Run by Biobeat Technologies Ltd. · NCT04071015 · Data updated 2026-11-12
This study is testing a new non-invasive blood pressure monitor to see if it gives accurate readings compared to traditional invasive methods right after heart surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | Biobeat Technologies Ltd. Industry-sponsored |
| Locations | 1 site (Ramat Gan) |
| Status | Recruiting |
| Started | June 15, 2020 |
| Main results expected | November 2026 |
| Study ends | December 2026 |
| Registry record updated | March 26, 2025 |
| Trial ID | NCT04071015 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who have undergone cardiac surgery and require blood pressure monitoring with an arterial line.
✕Probably not a fit
Patients who do not require an arterial line or those with mental illness or judgment issues may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical study aims to compare blood pressure measurements obtained from the Biobeat non-invasive monitoring device with those from invasive arterial line catheters and Swan Ganz catheters in patients immediately following cardiac surgery. The Biobeat device utilizes reflective photoplethysmography technology to measure vital signs such as blood pressure, heart rate, and cardiac output. The study will involve 20 patients in the cardiac intensive care unit, where vital signs will be recorded every 15 minutes for 4 hours after surgery. The goal is to assess the accuracy and reliability of the non-invasive method compared to traditional invasive techniques.
Why it matters
Potential benefit: If successful, this study could lead to safer and more convenient blood pressure monitoring methods for patients after cardiac surgery.
How similar studies have gone: Other studies have shown promising results with non-invasive monitoring technologies, suggesting potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
The Sheba Medical Center, Tel Hashomer
Ramat Gan, Israel Recruiting
Study contacts
- Principal investigator: Erez Kachel, MD — The Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel
- Study coordinator: Arik Eisenkraft, MD, MHA
- Email: dr.arik@bio-beat.gov
- Phone: +972-52-9210896
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.