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

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

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.

Study Overview

• Status: Completed
• Conditions: Critically Ill; Hemodynamic Instability
• Intervention / Treatment: Device: non-invasive monitoring

• Study Type: Observational
• Enrollment (Actual): 9

Contacts and Locations

Study Locations

• Israel
  • Rishon LeZion, Israel, 70300
    • The Assaf Harofeh Medical Center, Zrifin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted to the ICU unit, suffering from shock and in need for vasopressor support of more than 0.2 mcg/Kg/Min for a period longer than 3 hours, and that the treating physician has decided there is a need to insert a PiCCO catheter for invasive monitoring of their hemodynamic condition. Total period of monitoring will be up to 72 hours.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Biobeat Technologies Ltd.
• Collaborators: Assaf-Harofeh Medical Center
• Investigators: Principal Investigator: Ayana Dvir, MD, MHA, The Assaf Harofeh Medical Center, Tzrifin, Israel

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2019
• Primary Completion (Actual): April 15, 2021
• Study Completion (Actual): April 30, 2021

Study Registration Dates

• First Submitted: December 29, 2019
• First Submitted That Met QC Criteria: December 29, 2019
• First Posted (Actual): January 2, 2020

Study Record Updates

• Last Update Posted (Actual): July 7, 2021
• Last Update Submitted That Met QC Criteria: July 4, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: blood pressure; vital signs; Critically Ill patients; non-invasive monitoring; Vasopressor support
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: Biobeat004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: We plan to share the anonymised data within a manuscript (both analysed data and the raw vital sign data).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No