Comparison of Non-Invasive Blood Pressure (NIBP) Using the Biobeat Device with an Invasive Arterial Line Catheter
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBiobeat Technologies Ltd.
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
20 patients immediately after cardiac surgery arriving to the intensive care unit, and connected to an arterial line and or a Swan Ganz catheter transducer. Usually the arterial line is left for 24 hours. Right after arrival and once connected to an arterial line, the participants will be connected to the Biobeat monitor (both wristwatch or a patch). Vital signs will be monitored for 4 hours, and recorded every 15 minutes, for comparison. After 4 hours, the Biobeat monitor will be disconnected.
Trial design
Design model
Case-only
Time perspective
Retrospective
Treatments tested in this trial
Non-invasive monitoring
DeviceComparing blood pressure measurement using the Biobeat non-invasive monitor to arterial line.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Level of accordance between the Biobeat monitor and the arterial line
Comparing blood pressure measurements of the Biobeat device with those of the arterial line. Both systolic blood pressure and diastolic blood pressure will be assessed during the study period.
Time frame
4 hours per individualSponsors and contacts
Click on the lead sponsor to view all of their trials.
Biobeat Technologies Ltd.
Lead sponsor
The Chaim Sheba Medical Center
Collaborator
Source ClinicalTrials.gov