How end-tidal CO2 changes during a leg raise help predict if fluids will help ICU patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective observational study in the ICU tests whether changes in End-Tidal CO2 during a Passive Leg Raising maneuver can predict fluid responsiveness compared with a Mini Fluid Challenge. Eligible patients are adults on mechanical ventilation who are planned for a fluid bolus and have consent from a legal representative. The study uses EtCO2 delta as a non-invasive surrogate for cardiac output changes, validating results against LVOT-VTI or arterial pressure responses after the mini fluid challenge. It is single-center and focuses on improving fluid-resuscitation decisions to avoid fluid overload. The approach aims to identify a non-invasive, rapid bedside test to guide therapy in circulatory failure.

Why it matters

Who can join: the full rules

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.

Where it's running

• Izmir Katip Celebi University Atatürk Training and Research Hospital
  Izmir, Turkey (Türkiye) Recruiting

Study contacts

• Principal investigator: Murat Aksun, M.D. — Izmir Katip Celebi University Atatürk Training and Research Hospital
• Study coordinator: Murat Aksun, M.D.
• Email: murataksun@yahoo.com
• Phone: +90 552 363 16 14

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.