Niccomo-Card: Validity of Cardiac Output Measurement Using Niccomo Device After Cardiac Surgery

Sponsor

University Hospital, Rouen (Other)

Overall Status

Recruiting

CT.gov ID

NCT04643509

Collaborator

(none)

100

Enrollment

Location

24.1

Anticipated Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Shock, Cardiogenic Surgery Output, Low Cardiac	Device: Niccomo

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Cardiac Output Analysis by Cardiographic Impedance: a Validation Study of the Niccomo Non-invasive Monitor in Post-operative Cardiac Surgery

Actual Study Start Date :

Dec 18, 2020

Anticipated Primary Completion Date :

Dec 18, 2022

Anticipated Study Completion Date :

Dec 23, 2022

Arms and Interventions

Arm	Intervention/Treatment
cardiac surgery patients benefiting from pulmonary arterial catheter monitoring after cardiac surgery	Device: Niccomo Niccomo monitoring added to pulmonary arterial catheter monitoring

Arm

Intervention/Treatment

cardiac surgery

patients benefiting from pulmonary arterial catheter monitoring after cardiac surgery

Device: Niccomo

Niccomo monitoring added to pulmonary arterial catheter monitoring

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Systolic Time Ratio [48 hours]
Niccomo values at 10 different time-points
Pre-ejection Period [48 hours]
Niccomo values at 10 different time-points
Velocity Index [48 hours]
Niccomo values at 10 different time-points
Left Ventricular Ratio [48 hours]
Niccomo values at 10 different time-points

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rouen University Hospital	Rouen		France	76000

Sponsors and Collaborators

University Hospital, Rouen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Rouen

ClinicalTrials.gov Identifier:

NCT04643509

Other Study ID Numbers:

2019/020/OB

First Posted:

Nov 25, 2020

Last Update Posted:

Dec 24, 2020

Last Verified:

Nov 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Shock, Cardiogenic

Cardiac Output, Low

Study Results

No Results Posted as of Dec 24, 2020