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
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2020
CompletedFirst Posted
Study publicly available on registry
November 25, 2020
CompletedStudy Start
First participant enrolled
December 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 18, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 23, 2022
CompletedDecember 24, 2020
November 1, 2020
2 years
November 19, 2020
December 22, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Systolic Time Ratio
48 hours
Pre-ejection Period
48 hours
Velocity Index
48 hours
Left Ventricular Ratio
48 hours
Study Arms (1)
cardiac surgery
patients benefiting from pulmonary arterial catheter monitoring after cardiac surgery
Interventions
Eligibility Criteria
All patients bénéfiting from cardiac surgery and pulmonary arterial catheter at the discretion of the physician
You may qualify if:
- age \> 18 y/o
- Patients benefiting from cardiac surgery AND pulmonary arterial catheter monitoring
You may not qualify if:
- Aortic regurgitation grade 3-4
- Uncontrolled Hypertension (MAP \> 130 mmHg)
- Circulatory or cardiac assistance
- Active pacemaker
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rouen University Hospital
Rouen, 76000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2020
First Posted
November 25, 2020
Study Start
December 18, 2020
Primary Completion
December 18, 2022
Study Completion
December 23, 2022
Last Updated
December 24, 2020
Record last verified: 2020-11