Validity of Cardiac Output Measurement Using Niccomo Device After Cardiac Surgery (NCT04643509) | Clinical Trial Compass
UnknownNot Applicable
Validity of Cardiac Output Measurement Using Niccomo Device After Cardiac Surgery
France100 participantsStarted 2020-12-18
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing a non-invasive device called Niccomo against the standard pulmonary arterial catheter to measure heart output after cardiac surgery — can you explain what that means for my monitoring and whether one method might be more appropriate for my situation?
2Since this study's recruitment status is listed as unknown, can you find out whether it is still actively enrolling patients, and if not, whether the results have been published or shared in a way that might influence my care?
3This trial is listed as 'Phase NA,' which suggests it's more of a measurement validation study than a traditional drug or treatment trial — does that mean there's less risk involved, and how would participating actually change what happens to me during recovery?
4If I were to take part in this study, would I need to have both the Niccomo device and a pulmonary arterial catheter placed, and what are the risks of having a PAC inserted after cardiac surgery?
5Are there patients with low cardiac output or cardiogenic shock, like the conditions this trial focuses on, for whom one monitoring method is already considered more reliable, and would that affect whether this study is even relevant to my recovery plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
agreement between cardiac outputs measured by Pulmonary Arterial Catheter (PAC) and Niccomo