Role of End-Tidal CO2 During Passive Leg Raising to Predict Fluid Responsiveness in ICU (NCT07304648) | Clinical Trial Compass
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Role of End-Tidal CO2 During Passive Leg Raising to Predict Fluid Responsiveness in ICU
Turkey (Türkiye)68 participantsStarted 2026-01-01
Plain-language summary
This prospective observational study evaluates whether monitoring changes in exhaled carbon dioxide (End-Tidal CO2 or EtCO2) during a "Passive Leg Raising" (PLR) test can reliably predict fluid responsiveness in critically ill patients.
In the Intensive Care Unit (ICU), fluid management is a critical balance; while fluid is necessary for tissue perfusion, overload can lead to severe complications. Traditional static measurements (like central venous pressure) are often unreliable for guiding therapy. Dynamic tests like PLR are preferred as they simulate a fluid bolus reversibly by shifting blood from the legs to the heart.
Researchers will observe mechanically ventilated patients planned for fluid resuscitation. The study compares the accuracy of non-invasive EtCO2 changes during PLR against a reference standard "Mini Fluid Challenge" (100 mL fluid administration). Fluid responsiveness will be confirmed using echocardiographic measurements (LVOT-VTI) or arterial pressure changes. The goal is to validate EtCO2 as a practical, real-time tool for safe fluid management.
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:
* Patients aged 18 years or older.
* Patients who have been followed in the intensive care unit (ICU) with mechanical ventilation support for at least 24 hours.
* Patients for whom a mini fluid challenge (MFC) is clinically planned by the intensive care team.
* Patients for whom informed consent has been obtained from first-degree relatives or a legal representative.
Exclusion Criteria:
* Patients younger than 18 years of age.
* Pregnant patients.
* Patients without consent from first-degree relatives or a legal representative.
* Patients with known deep vein thrombosis (DVT) in the leg veins (risk of embolism during leg raising).
* Patients with pathologies that may cause increased intracranial pressure (e.g., intracranial mass, hemorrhage).
* Patients with uncontrolled hypertension.
* Patients with severe cardiac disease (e.g., right heart failure, pulmonary hypertension, advanced valvular pathology).
* Patients with carbon dioxide (CO2) retention.
* Patients who have undergone hip surgery or hip replacement surgery where Passive Leg Raising (PLR) cannot be performed.
* Patients with spontaneous breathing.
* Patients with a probability of high intra-abdominal pressure.
* Patients who cannot lie in a supine position.
* Patients with current peripheral oxygen saturation (SpO2) \< 88%.
* Patients on mechanical ventilation requiring pressure support \> 16 mmHg or PEEP \> 10 mmHg.
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.
What they're measuring
1
Change in End-Tidal Carbon Dioxide (Delta EtCO2) during Passive Leg Raising (PLR)
Timeframe: Measured between 60 to 90 seconds after the position change.