Evaluation of Transthoracic Ultrasonography in Differentiating Pleural Effusions

NCT07513909 | Not Yet Recruiting

• 1 other identifier: US in Pleural Effusions
• Study Type: observational
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pleural Effusion; Transudative Pleural Effusion; Exudative Pleural Effusion

Keywords

Chest Ultrasound; Computed Tomography; Transudate; Exudate; Light's Criteria; Thoracentesis

Outcome Measures

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.

  Up to 48 hours post-enrollment (Imaging and thoracentesis are performed within 24-48 hours of each other)

Study Arms (1)

Pleural Effusion Cohort

Adult patients (18 years or older) presenting with clinically and radiologically confirmed pleural effusion. All participants in this cohort will undergo a chest ultrasound and a diagnostic thoracentesis within 24 to 48 hours of each other. The pleural fluid obtained via thoracentesis will be analyzed using Light's criteria, which will serve as the reference standard to evaluate the diagnostic accuracy of the ultrasound.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Pleural Effusion; Hydrothorax

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at Chest Department, Assiut University

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 7, 2026
• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04