Comparison Studies Comparing Hemodynamic Parameters Provi... | NCT05035719

Studies
Comparison Studies Comparing Hemodynamic Parameters Provided by the Caretaker Against Respective Gold Standard References

NCT05035719

Sponsor

CareTaker Medical LLC

Status

Unknown status

Last Update Posted

Sep 5, 2021Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Cardiac Output, Low

Interventions

non-invasive cardiac output monitor

Countries

United States

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

Aug 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2021Actual

Primary Completion Date

Mar 31, 2022Estimated

Completion Date

Mar 31, 2022Estimated

First Submitted Date

Aug 31, 2021

First Submission Date that Met QC Criteria

Sep 1, 2021

First Posted Date

Sep 5, 2021Actual

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

Sep 1, 2021

Last Update Posted Date

Sep 5, 2021Actual

Name	Class
The Cooper Health System	OTHER

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

Comparison studies comparing hemodynamic parameters provided by the Caretaker against respective Gold Standard references.

Detailed Description

Comparison study comparing hemodynamic parameters provided by the Caretaker against respective Gold Standard references.

Specifically, continuous beat-by-beat blood pressure readings against arterial catheter readings and cardiac output (CO) and stroke volume (SV) measures against thermo-dilution measurements

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

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1		Cardiac patients	Device: non-invasive cardiac output monitor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
non-invasive cardiac output monitor	Device	Equivalence of Caretaker cardiac output reading to reference standard	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cardiac output performance comparison	Comparison with thermo-dilution-based cardiac output, agreement within 1 l/min.	Change between several paired readings over the course of cardiac surgery (typically 2-4 hours)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years of age
able and willing to participate
provide written consent

Exclusion Criteria:

Unable to give written consent
<18 years of age
No or poor finger pulse, as determined through visual inspection for ischemic hands

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Cardiac patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Martin C Baruch, PhD	Contact	434 978-7000	103	martin@caretakermedical.net

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cooper University Hospital	Recruiting	Camden	New Jersey	08103	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002303	Cardiac Output, Low

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided