Validity of Cardiac Output Measurement Using Niccomo Devi... | NCT04643509

Studies
Validity of Cardiac Output Measurement Using Niccomo Device After Cardiac Surgery

NCT04643509

Sponsor

University Hospital, Rouen

Status

Unknown status

Last Update Posted

Dec 24, 2020Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Shock, Cardiogenic
Surgery
Output, Low Cardiac

Interventions

Niccomo

Countries

France

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

Nov 2020

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

Dec 18, 2020Actual

Primary Completion Date

Dec 18, 2022Estimated

Completion Date

Dec 23, 2022Estimated

First Submitted Date

Nov 19, 2020

First Submission Date that Met QC Criteria

Nov 19, 2020

First Posted Date

Nov 25, 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

Dec 22, 2020

Last Update Posted Date

Dec 24, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Cardiac surgery is at high risk of low cardiac output syndrome after procedure. Monitoring cardiac function, and especially cardiac output, is important to identify cardiovascular dysfunction and to introduce and adjust optimal therapies. Invasive monitor such as pulmonary arterial catheter or transpulmonary thermodilution provide precise measurements but need an invasive access to arterial and central venous route, with possible complications.

Cardiographic bioimpedencemetry (Niccomo device, Imedex Corp) allows a non invasive measurement of cardiac output and some other parameters of cardiovascular function. Nevertheless, the reliability of this device has been little studied after cardiac surgery.

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cardiac surgery		patients benefiting from pulmonary arterial catheter monitoring after cardiac surgery	Device: Niccomo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Niccomo	Device	Niccomo monitoring added to pulmonary arterial catheter monitoring	cardiac surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
agreement between cardiac outputs measured by Pulmonary Arterial Catheter (PAC) and Niccomo	Cardiac outputs and systolic ejection volumes are measured at 10 different time-points and agreement between the 2 devices are explored	48 hours

Secondary Outcomes

Measure	Description	Time Frame
Systolic Time Ratio	Niccomo values at 10 different time-points	48 hours
Pre-ejection Period	Niccomo values at 10 different time-points

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age > 18 y/o
Patients benefiting from cardiac surgery AND pulmonary arterial catheter monitoring

Exclusion Criteria:

Aortic regurgitation grade 3-4
Uncontrolled Hypertension (MAP > 130 mmHg)
Circulatory or cardiac assistance
Active pacemaker

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

All patients bénéfiting from cardiac surgery and pulmonary arterial catheter at the discretion of the physician

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Emmanuel Besnier, MD PhD	Contact	+33232881705		emmanuel.besnier@chu-rouen.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rouen University Hospital	Recruiting	Rouen		76000	France

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
D012770	Shock, Cardiogenic
D002303	Cardiac Output, Low

Ancestor Terms

ID	Term
D009203	Myocardial Infarction
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided