Trials / Completed
CompletedNCT03603860
Comparison of the Non-invasive Biobeat Device With an Invasive Arterial Line
Comparison of Continuous Blood Pressure Measurement Using the Non-invasive, Wireless Biobeat Monitor With an Invasive Arterial Line
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 18 (actual)
- Sponsor
- Biobeat Technologies Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
In this clinical study the investigators will compare blood pressure measurements obtained using the non-invasive, continuous and wireless Biobeat monitoring device (a wrist watch or a patch configuration) to an invasive arterial line (radial or femoral) in 30 patients immediately after cardiac surgery, at the intensive care unit.
Detailed description
The Biobeat non-invasive, continuous and wireless monitoring device is based on photoplethysmograph technology. It measures several vital signs, including blood pressure, stroke volume, pulse rate, pulse pressure, heart rate variability, respiratory rate, saturation, cardiac output, cardiac index, and more. The data is transmitted to Biobeat's application (in both Apple and Google Play), and is available on the individual's cellular phone, tablet, or as a full monitoring system in a hospital department. The aim of this study is to compare the Biobeat monitor with the invasive method of blood pressure measurement, an arterial line. The study population includes 30 patients undergoing cardiac surgery. As per local protocol, each one of the participants will come out from the operating room with an arterial line. Once in the intensive care unit, the investigators will attach the Biobeat non-invasive monitor (either wrist watch or a patch, these two configurations are identical in terms of the monitoring system), and monitor the participants for 4 hours. Though both methods are continuous, the investigators will record the vital signs every 15 minutes during the 4 hours of the study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Non-invasive monitoring | Comparing blood pressure measurement using the Biobeat non-invasive monitor to arterial line |
Timeline
- Start date
- 2018-11-05
- Primary completion
- 2020-02-05
- Completion
- 2020-03-05
- First posted
- 2018-07-27
- Last updated
- 2020-07-09
Locations
1 site across 1 country: Israel
Source: ClinicalTrials.gov record NCT03603860. Inclusion in this directory is not an endorsement.