Comparing the PiCCO Monitor to the Non-invasive Biobeat (... | NCT04215627

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

NCT04215627

Sponsor

Biobeat Technologies Ltd.

Status

Completed

Last Update Posted

Jul 7, 2021Actual

Enrollment

9Actual

Phase

Not provided

Conditions

Critically Ill
Hemodynamic Instability

Interventions

non-invasive monitoring

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 26, 2019Actual

Primary Completion Date

Apr 15, 2021Actual

Completion Date

Apr 30, 2021Actual

First Submitted Date

Dec 29, 2019

First Submission Date that Met QC Criteria

Dec 29, 2019

First Posted Date

Jan 2, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 4, 2021

Last Update Posted Date

Jul 7, 2021Actual

Name	Class
Assaf-Harofeh Medical Center	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
non-invasive monitoring	Device	Comparing the PiCCO monitor to the non-invasive BB-613PW device in hemodynamically unstable critically ill patients in the ICU		BB-613PW

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ayana Dvir, MD, MHA	The Assaf Harofeh Medical Center, Tzrifin, Israel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Assaf Harofeh Medical Center, Zrifin		Rishon LeZiyyon		70300	Israel

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

We plan to share the anonymised data within a manuscript (both analysed data and the raw vital sign data).

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016638	Critical Illness

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided