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

NCT04215627 | Completed FDA Device

• 1 other identifier: Biobeat004
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Critically Ill; Hemodynamic Instability

Keywords

Critically Ill patients; blood pressure; vital signs; non-invasive monitoring; Vasopressor support

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

non-invasive monitoring DEVICE

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

Also known as: BB-613PW

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Refusal of the subject
• Technical difficulties in insertion of the PiCCO catheters
• Significant cardiac arrhythmias
• Significant valvular disease
• Pregnancy

Sponsors & Collaborators

• Biobeat Technologies Ltd.: lead
• Assaf-Harofeh Medical Center: collaborator

Study Sites (1)

The Assaf Harofeh Medical Center, Zrifin

Rishon LeZiyyon, 70300, Israel

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ayana Dvir, MD, MHA

  The Assaf Harofeh Medical Center, Tzrifin, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2019
• First Posted: January 2, 2020
• Study Start: December 26, 2019
• Primary Completion: April 15, 2021
• Study Completion: April 30, 2021
• Last Updated: July 7, 2021

Record last verified: 2021-07

Locations

IL (1)