Skip to main content
OpenTrials
Completed

NCT Number: NCT04215627

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Critically Ill Critical Illness Disease Attributes Hemodynamic Instability Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Assaf Harofeh Medical Center, Zrifin

Rishon LeZiyyon, 70300, Israel

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-invasive monitoring

Device

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

Other names: BB-613PW

Primary outcomes

  1. Level of accordance between the BB-613PW to the PiCCO

    Time frame: 72 hours per individual

    We will compare the level of accordance of blood pressure, heart rate, stroke volume, cardiac output, heart rate variability, and systemic vascular resistance.

Sponsors and collaborators

Lead sponsor

Biobeat Technologies Ltd.

Industry

Collaborators

  • Assaf-Harofeh Medical Center

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 2, 2020
Registry last updated
Jul 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.