Comparing non-invasive blood pressure monitoring with invasive methods after cardiac surgery
Comparison of Continuous Non-Invasive Blood Pressure Measurement Using the Wireless Cuffless Biobeat Monitor with an Invasive Arterial Line Catheter
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 |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Biobeat Technologies Ltd. Industry-sponsored |
| Locations | 1 site (Ramat Gan) |
| Trial ID | NCT04071015 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have undergone cardiac surgery and require blood pressure monitoring with an arterial line.
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.
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 performed: Other studies have shown promising results with non-invasive monitoring technologies, suggesting potential for success in this approach.
Eligibility criteria
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 this trial is running
Ramat Gan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.