Evaluation of Transthoracic Ultrasonography in Differentiating Pleural Effusions
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University
About this trial
Pleural effusion is a condition where excess fluid builds up in the space between the lungs and the chest wall. To properly treat this condition, doctors must determine if the fluid is a "transudate" (usually resulting from systemic conditions like heart failure or liver disease) or an "exudate" (often resulting from local issues like infections, inflammation, or cancer). The standard method to classify this fluid involves inserting a needle into the chest to draw out a sample for laboratory testing, a procedure known as thoracentesis.
While laboratory fluid analysis is highly accurate, the needle procedure carries some inherent procedural risks. This observational study aims to evaluate whether non-invasive imaging tests, specifically chest ultrasound, can accurately determine if the fluid is a transudate or an exudate.
Researchers will enroll adult patients presenting with pleural effusion at Assiut University Hospital. As part of their diagnostic workup, participants will undergo a chest ultrasound and a standard diagnostic thoracentesis (fluid draw) within 24 to 48 hours of each other. The study will then evaluate the features seen on the ultrasound against the laboratory fluid analysis (the current gold standard) to see how well the non-invasive imaging performs in identifying the specific type of pleural effusion.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients aged ≥18 years of either sex
Clinically and radiologically documented pleural effusion (confirmed by chest X-ray and/or thoracic ultrasound)
Patients scheduled for diagnostic or therapeutic thoracentesis as part of their standard clinical care
Ability to provide written informed consent
Disqualifiers
Patients with a history of prior pleural interventions, including chemical or surgical pleurodesis or previous chest tube insertion on the affected side
Patients with absolute contraindications to thoracentesis (e.g., uncorrectable coagulopathy, uncooperative patients, or hemodynamic instability)
Poor transthoracic ultrasound window preventing adequate evaluation of the pleural space (e.g., due to severe obesity, extensive subcutaneous emphysema, or chest wall deformities)
Patients with traumatic hemothorax.
Trial population
The study population comprises adult patients (18 years or older) of both sexes presenting with a clinically and radiologically confirmed pleural effusion (unilateral or bilateral). Participants will be recruited from patients admitted to the Chest Medicine Department or referred for imaging at Assiut University Hospital. Eligible participants are those scheduled to undergo diagnostic thoracentesis and ultrasound of the chest as part of their standard clinical diagnostic workup.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
90 Participants
are grouped into 1 trial groupGroup A: Pleural Effusion Cohort
Trial outcomes
Primary outcomes
1
Diagnostic Accuracy of Chest Ultrasound Measured by Area Under the Curve (AUC)
The overall diagnostic accuracy of chest ultrasound in differentiating exudative from transudative pleural effusions will be evaluated by calculating the Area Under the Receiver Operating Characteristic Curve (AUC). Sonographic features (such as echogenicity and septations) will be assessed and validated against the biochemical reference standard (Light's criteria) obtained from pleural fluid analysis via thoracentesis.
Time frame
Up to 48 hours post-enrollment (Imaging and thoracentesis are performed within 24-48 hours of each other)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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