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NCT04215627 Clinical Trial

Comparing the PiCCO Monitor to the Non-invasive Biobeat (BB)-316PW in ICU Patients

Critically Ill Clinical Trial

Official title:
Comparison Between Invasive Hemodynamic Monitoring, Using the PiCCO Monitor, to a Non-invasive Photoplethysmography Based Device in Hemodynamic Unstable Critically Ill Patients, With Vasopressor Support

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04215627
Other study ID # Biobeat004
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 26, 2019
Est. completion date April 30, 2021

Study information
Verified date July 2021
Source Biobeat Technologies Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to compare hemodynamic monitoring using the invasive PiCCO device to the BB-613PW wireless, non-invasive PPG-based device, in critically ill patients within the ICU, suffering from hemodynamic instability and in need of vasopressor support. Data will be gathered prospectively and analysed retrospectively.

Recruitment information / eligibility
Status Completed
Enrollment 9
Est. completion date April 30, 2021
Est. primary completion date April 15, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - ICU adult patients in the need of vasopressor support of more than 0.2 mcg/Kg/Min for a period longer than 3 hours - Patients in which PiCCO monitoring is needed Exclusion Criteria: - Refusal of the subject - Technical difficulties in insertion of the PiCCO catheters - Significant cardiac arrhythmias - Significant valvular disease - Pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• non-invasive monitoring
Comparing the PiCCO monitor to the non-invasive BB-613PW device in hemodynamically unstable critically ill patients in the ICU

Locations
Country Name City State
Israel The Assaf Harofeh Medical Center, Zrifin Rishon LeZion

Sponsors (2)
Lead Sponsor Collaborator
Biobeat Technologies Ltd. Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Level of accordance between the BB-613PW to the PiCCO We will compare the level of accordance of blood pressure, heart rate, stroke volume, cardiac output, heart rate variability, and systemic vascular resistance. 72 hours per individual
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