Real-time Continuous Cardiac Output Measurements | NCT04774978

Studies
Real-time Continuous Cardiac Output Measurements

NCT04774978

Sponsor

Rijnstate Hospital

Status

Unknown status

Last Update Posted

Mar 1, 2021Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Cardiac Output, Low

Interventions

Countries

Not provided

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

Feb 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2021Estimated

Primary Completion Date

Mar 1, 2022Estimated

Completion Date

Jul 1, 2022Estimated

First Submitted Date

Feb 25, 2021

First Submission Date that Met QC Criteria

Feb 25, 2021

First Posted Date

Mar 1, 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

Feb 25, 2021

Last Update Posted Date

Mar 1, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Study to assess the feasibility of real-time automatic cardiac output measurements using transthoracic echocardiography (TTE)

Detailed Description

Rationale: Study to assess the feasibility of real-time automatic cardiac output measurements using transthoracic echocardiography (TTE)

Objective: To assess the correlation and feasibility of real-time automatic continuous cardiac output measurements using transthoracic ultrasound (TTE) in adult ICU-patients in comparison to Flotrac measurements

Study design: prospective, feasibility study

Study population: Adult Intensive Care patients ( > 18 years)

Intervention (if applicable):

Consecutive adult patients on the ICU in which the there is an indication for continuous cardiac output measurements.

Main study parameters/endpoints:

Percentage of patients in which continuous cardiac output can be measured using TTE
Correlation between continuous TTE and Flotrac measurements

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cardiac output measurements	Experimental	Cardiac output will be measured using TTE continuously with ProbeFix	Device: TTE

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TTE	Device	Transthoracic echocardiography	Cardiac output measurements

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patients in which the ProbeFix can be used continuously	Percentages will be reported	2 months

Secondary Outcomes

Measure	Description	Time Frame
Correlation between continuous TTE and Flotrac	Bland-Altman plot will be reported	2 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult Intensive Care patients ( > 18 years)

Exclusion Criteria:

Pregnancy
Atrial fibrillation or other irregular heart rhythm

Accepts Healthy Volunteers

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
B Baten	Contact	088 - 0057870		BBaten@rijnstate.nl

Overall Officials

Not provided

Locations

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