Validity of Cardiac Output Measurement Using Niccomo Device After Cardiac Surgery

• Conditions: Shock, Cardiogenic; Surgery; Output, Low Cardiac
• Interventions: Device: Niccomo

• Registration Number: NCT04643509
• Lead Sponsor: University Hospital, Rouen

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 available

Study Timeline

• Status Verified: 2020-11
• Study First Submitted: 2020-11-19
• Study First Submitted QC: 2020-11-19
• Study First Posted: 2020-11-25
• Study Start: 2020-12-18
• Last Update Submitted: 2020-12-22
• Last Update Posted: 2020-12-24
• Primary Completion: 2022-12-18
• Study Completion: 2022-12-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
cardiac surgery	Niccomo	patients benefiting from pulmonary arterial catheter monitoring after cardiac surgery

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Systolic Time Ratio	48 hours	Niccomo values at 10 different time-points
Left Ventricular 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

Trial Locations

Locations (1)

Rouen University Hospital; 🇫🇷 Rouen, France