Role of End-Tidal CO2 During Passive Leg Raising to Predict Fluid Responsiveness in ICU

NCT07304648 · tracked via the Priya Life Science Turkey tracker

Sponsor

Izmir Katip Celebi University

Phase

Observational

Started

2026-01-01

Last updated

2025-12-26

Condition(s) studied

Circulatory FailureCritical IllnessHypovolemia

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Change in End-Tidal Carbon Dioxide (Delta EtCO2) during Passive Leg Raising (PLR) — Measured between 60 to 90 seconds after the position change.
The absolute difference in End-Tidal CO2 (EtCO2) levels will be calculated between the baseline measurement (T0, patient semi-recumbent at 45°) and the measurement taken during the Passive Leg Raising test (T1, patient supine with legs raised to 45°). The diagnostic accuracy of this Delta EtCO2 will be evaluated by comparing it against the patient's fluid responsiveness status (Responder vs. Non-Responder) determined by the subsequent Mini Fluid Challenge.

Trial sites (1)

Facility	City	Region	Status
Izmir Katip Celebi University Atatürk Training and Research Hospital	Izmir	Turkey (Türkiye)

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07304648 on ClinicalTrials.gov ↗ ← All trials in Turkey