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

Completed

• Conditions: Hemodynamic Instability; Critically Ill

• Registration Number: NCT04215627
• Lead Sponsor: Biobeat Technologies Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-26
• Study First Submitted: 2019-12-29
• Study First Submitted QC: 2019-12-29
• Study First Posted: 2020-01-02
• Primary Completion: 2021-04-15
• Study Completion: 2021-04-30
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-04
• Last Update Posted: 2021-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Level of accordance between the BB-613PW to the PiCCO	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.

Trial Locations

Locations (1)

The Assaf Harofeh Medical Center, Zrifin; 🇮🇱 Rishon LeZion, Israel