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

NCT ID: NCT04215627

Last Updated: 2021-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-26

Study Completion Date

2021-04-30

Brief Summary

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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

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Conditions

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Critically Ill Hemodynamic Instability

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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non-invasive monitoring

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

Intervention Type DEVICE

Other Intervention Names

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BB-613PW

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role collaborator

Biobeat Technologies Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ayana Dvir, MD, MHA

Role: PRINCIPAL_INVESTIGATOR

The Assaf Harofeh Medical Center, Tzrifin, Israel

Locations

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The Assaf Harofeh Medical Center, Zrifin

Rishon LeZiyyon, , Israel

Site Status

Countries

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Israel

Other Identifiers

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Biobeat004

Identifier Type: -

Identifier Source: org_study_id

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