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Clinical Trials/NCT04643509
NCT04643509
Unknown
Not Applicable

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

University Hospital, Rouen1 site in 1 country100 target enrollmentDecember 18, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Shock, Cardiogenic
Sponsor
University Hospital, Rouen
Enrollment
100
Locations
1
Primary Endpoint
agreement between cardiac outputs measured by Pulmonary Arterial Catheter (PAC) and Niccomo
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 18, 2020
End Date
December 23, 2022
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Rouen
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

agreement between cardiac outputs measured by Pulmonary Arterial Catheter (PAC) and Niccomo

Time Frame: 48 hours

Cardiac outputs and systolic ejection volumes are measured at 10 different time-points and agreement between the 2 devices are explored

Secondary Outcomes

  • Left Ventricular Ratio(48 hours)
  • Pre-ejection Period(48 hours)
  • Systolic Time Ratio(48 hours)
  • Velocity Index(48 hours)

Study Sites (1)

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