Validity of Cardiac Output Measurement Using Niccomo Device After Cardiac Surgery

Surgery Clinical Trial

— Niccomo-Card  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04643509
• Other study ID #: 2019/020/OB
• Status: Recruiting
• Start date: December 18, 2020
• Est. completion date: December 23, 2022

Study information

• Verified date: November 2020
• Source: University Hospital, Rouen
• Contact: Emmanuel Besnier, MD PhD
• Phone: +33232881705
• Email: emmanuel.besnier[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 23, 2022
• Est. primary completion date: December 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Output, Low
• Output, Low Cardiac
• Shock, Cardiogenic
• Surgery

Intervention

Device:
• Niccomo
Niccomo monitoring added to pulmonary arterial catheter monitoring

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Systolic Time Ratio	Niccomo values at 10 different time-points	48 hours
Secondary	Pre-ejection Period	Niccomo values at 10 different time-points	48 hours
Secondary	Velocity Index	Niccomo values at 10 different time-points	48 hours
Secondary	Left Ventricular Ratio	Niccomo values at 10 different time-points	48 hours