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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04215627
Enrollment
9
Registered
2020-01-02
Start date
2019-12-26
Completion date
2021-04-30
Last updated
2021-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critically Ill, Hemodynamic Instability

Keywords

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

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.

Interventions

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

Sponsors

Assaf-Harofeh Medical Center
CollaboratorOTHER_GOV
Biobeat Technologies Ltd.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Level of accordance between the BB-613PW to the PiCCO72 hours per individualWe will compare the level of accordance of blood pressure, heart rate, stroke volume, cardiac output, heart rate variability, and systemic vascular resistance.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026