Validity of Cardiac Output Measurement Using Niccomo Device After Cardiac Surgery

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04643509

Acronym

Niccomo-Card

Enrollment

100

Registered

2020-11-25

Start date

2020-12-18

Completion date

2022-12-23

Last updated

2020-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Output, Low Cardiac, Shock, Cardiogenic, Surgery

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.

Interventions

DEVICENiccomo

Niccomo monitoring added to pulmonary arterial catheter monitoring

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

France

Contacts

Primary ContactEmmanuel Besnier, MD PhD

emmanuel.besnier@chu-rouen.fr+33232881705

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026