Thoracic Fluid Content by Bioimpedance-based Starling System (NCT05676723) | Clinical Trial Compass
CompletedNot Applicable
Thoracic Fluid Content by Bioimpedance-based Starling System
France41 participantsStarted 2022-01-18
Plain-language summary
The Starling system is a completely non-invasive hemodynamic monitoring technique. It is able to measure the thoracic fluid content (TFC). The TFC is supposed to reflect the total content of fluid in the thorax. Thus, TFC may include two of the variables that are commonly used for hemodynamic monitoring: the extravascular lung water (EVLW), and the global end-diastolic volume (GEDV). However, whether the TFC actually reflects GEDV and EVLW has not been clearly established. The objective of the study is to establish the determinants of TFC among hemodynamic variables including EVLW and GEDV.
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.
* Hospitalization in an ICU
* Monitoring by transpulmonary thermodilution already in place
* Decision by clinicians in charge to perform volume expansion by saline or fluid removal by diuretics infusion and/or ultrafiltration ("Fluid" group)
* Or presence of Acute Respiratory Distress Syndrome according to the Berlin definition ("ARDS" group)
Exclusion Criteria:
* Refusal to join the study
* In "Fluid" group, circulatory failure whose treatment cannot be postponed for ≥5 minutes (time required for the installation of Starling system).
* Impossibility to paste bioreactance electrodes properly in the skin of the thorax.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.