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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Surgery; Shock, Cardiogenic; Output, Low Cardiac
• Intervention / Treatment: Device: Niccomo

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Emmanuel Besnier, MD PhD; Phone Number: +33232881705; Email: emmanuel.besnier@chu-rouen.fr

Study Locations

• France
  • Rouen, France, 76000
    • Recruiting
    • ROUEN university hospital
    • Contact: emmanuel besnier, MD; Phone Number: +33 2 32 88 82 83; Email: emmanuel.besnier@chu-rouen.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	48 hours
Velocity Index	Niccomo values at 10 different time-points	48 hours
Left Ventricular Ratio	Niccomo values at 10 different time-points	48 hours

Collaborators and Investigators

• Sponsor: University Hospital, Rouen

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2020
• Primary Completion (Anticipated): December 18, 2022
• Study Completion (Anticipated): December 23, 2022

Study Registration Dates

• First Submitted: November 19, 2020
• First Submitted That Met QC Criteria: November 19, 2020
• First Posted (Actual): November 25, 2020

Study Record Updates

• Last Update Posted (Actual): December 24, 2020
• Last Update Submitted That Met QC Criteria: December 22, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Shock; Myocardial Infarction; Infarction; Shock, Cardiogenic; Cardiac Output, Low
• Other Study ID Numbers: 2019/020/OB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No