An interventional study of Serial Bedside Lung Ultrasound (LUS) Protocol in Pleural Effusion Disorder, Re-expansion Pulmonary Edema and Pulmonary Edemas, sponsored by Delta University for Science and Technology. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Delta University for Science and Technology · Not applicable, Interventional, and Diagnostic
This study evaluates the feasibility, safety, and predictive role of dynamic bedside Lung Ultrasound (LUS) during therapeutic thoracocentesis in patients with moderate-to-massive pleural effusions. Re-expansion pulmonary edema (RPE) is a rare but potentially life-threatening complication of rapid pleural fluid drainage. In this single-arm pilot study, participants undergo therapeutic thoracocentesis guided by serial LUS assessments performed at predefined drainage volume milestones (T0: baseline, T1: 500 mL, T2: 1000 mL, T_3: 1500 mL, and T End). Rather than relying solely on predetermined total drainage limits, procedure modification or early termination is dynamically guided by real-time ultrasound findings (such as coalescent B-lines and subpleural consolidations) alongside clinical monitoring. The main goal is to assess whether serial LUS monitoring can reliably detect early sonographic features of evolving pulmonary edema and inform clinical decision-making during pleural fluid removal.
Background and Rationale
Pleural effusion may cause substantial lung compression, impaired pulmonary re-expansion, and clinically significant respiratory symptoms. Therapeutic thoracocentesis is an established intervention for symptomatic relief; however, rapid removal of a large pleural fluid volume may result in abrupt changes in pleural pressure and pulmonary mechanics, potentially contributing to re-expansion pulmonary edema (RPE). Although RPE is an uncommon complication, its potentially serious clinical consequences highlight the need for reliable real-time indicators of pulmonary response during drainage.
Lung ultrasound (LUS) is a portable, radiation-free bedside imaging modality that enables real-time assessment of lung aeration, pleural-line characteristics, and interstitial and subpleural abnormalities. Despite its increasing use in acute respiratory care, prospective evidence evaluating serial LUS as a dynamic safety and decision-support tool during active therapeutic thoracocentesis remains limited.
Study Design and Interventional Algorithm
This prospective, single-center, single-arm interventional pilot study will recruit consecutive adult patients undergoing therapeutic thoracocentesis at Mansoura University Hospitals.
All participants will undergo standardized serial LUS assessments at predefined drainage milestones: **T₀ (baseline), T₁ (500 mL), T₂ (1000 mL), T₃ (1500 mL), and TEnd (procedure completion or premature termination).
Serial assessments will characterize dynamic changes in:
Action Thresholds and Decision Protocol
A predefined LUS-guided decision algorithm will be used to support real-time modification of the drainage procedure. The development of potentially concerning sonographic changes-particularly rapid emergence or progression of diffuse/coalescent B-lines or new subpleural abnormalities, especially when accompanied by clinical or physiological deterioration-will trigger temporary interruption of fluid drainage and immediate reassessment of the patient's clinical status and vital signs.
If sonographic or clinical abnormalities persist or progress, the drainage rate will be reduced or thoracocentesis will be terminated, irrespective of the remaining pleural fluid volume. Appropriate supportive measures, including supplemental oxygen when clinically indicated, will be provided.
Feasibility and Safety Outcomes
As an exploratory pilot study with a pragmatic target sample of 40-50 consecutive participants, the primary objectives are to evaluate the feasibility, protocol adherence, safety, and operational performance of serial LUS-guided monitoring during therapeutic thoracocentesis.
Secondary exploratory assessments will include characterization of the relationship between drainage volume/rate and dynamic LUS aeration changes, documentation of protocol-triggered drainage modification or termination, and estimation of the short-term incidence of RPE and other post-procedural respiratory complications.
The findings will be used to generate preliminary estimates of outcome frequency, effect size, and variability and to inform the design and sample-size calculation of a subsequent adequately powered multicenter prospective comparative study.
335 studies on the registry are indexed under Pleural Effusion; 63 are open to participants now.
This study's enrollment of 23 is below the median of 62 across 220 interventional studies indexed under Pleural Effusion.
Browse Pleural Effusion studies →Delta University for Science and Technology is the lead sponsor of 86 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
Patients undergo ultrasound-guided therapeutic thoracocentesis with serial bedside Lung Ultrasound (LUS) assessments at predefined volume milestones (T0: baseline, T1: 500 mL, T2: 1000 mL, T3: 1500 mL, TEnd: completion). Procedures are dynamically modified, paused, or terminated based on real-time sonographic warning features (such as coalescent B-lines and subpleural consolidations) alongside clinical parameters.
Diagnostic Test: Serial Bedside Lung Ultrasound (LUS) Protocol
Standardized real-time serial lung ultrasound evaluations performed during therapeutic thoracocentesis to monitor lung aeration, B-line dynamics, pleural line changes, and subpleural consolidations to guide fluid drainage speed or procedure termination.
Total Drained Pleural Fluid Volume
Total volume of pleural fluid removed from initiation to completion/termination of thoracocentesis.
Time frame: At procedure completion (up to 2 hours).
Drainage Velocity
The speed of fluid removal calculated as total drained volume divided by the total duration of the procedure.
Time frame: At procedure completion (up to 2 hours).
Change in Lung Aeration Score (LUS) Across Procedural Milestones
Dynamic shift in lung aeration evaluated at sequential milestones (T0, T1, T2, T3, TEnd). The Lung Ultrasound Score evaluates 12 chest zones, with each zone scored from 0 to 3 (0 = Normal re-aeration, 1 = ≥3 well-spaced B-lines, 2 = Coalescent B-lines, 3 = Complete loss of aeration). Total LUS ranges from 0 (minimum/best outcome) to 36 (maximum/worst outcome). Higher scores represent worse lung aeration and fluid accumulation.
Time frame: Baseline (T0) to procedure completion (TEnd, approximately 1 to 2 hours).
Incidence of Oxygen Saturation Drop Following Thoracocentesis
Percentage of participants experiencing a clinically significant drop in SpO2 defined as a decrease of 4% or more from baseline T0.
Time frame: From initiation of procedure up to 48 hours post-procedure.
Requirement for Mechanical Ventilatory Support
Percentage of participants requiring new initiation of non-invasive positive pressure ventilation (NIPPV) or invasive mechanical ventilation due to respiratory decompensation.
Time frame: From initiation of procedure up to 48 hours post-procedure.
Rate of Unplanned Intensive Care Unit (ICU) Admissions
Percentage of participants transferred to the Intensive Care Unit due to severe post-procedural respiratory deterioration or complications.
Time frame: From initiation of procedure up to 48 hours post-procedure.
Incidence of Re-Expansion Pulmonary Edema (RPE)
Percentage of participants developing clinical or dynamic LUS-defined features of early or full-stage Re-Expansion Pulmonary Edema.
Time frame: From initiation of procedure up to 48 hours post-procedure.
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Plan to share: Yes — De-identified individual participant data (including LUS aeration scores, drainage volumes, and clinical parameters) will be made available upon reasonable request to the corresponding author, following peer-reviewed manuscript publication.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data will become available immediately following publication for a period of up to 3 years.
Access criteria: Data will be shared with qualified academic researchers for meta-analyses or secondary research after approval of a formal research proposal.
Ran from Sep 2025 to primary completion in Sep 2026, 12 months.
Of 71 non-industry interventional studies with no phase under Pleural Effusion, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 55. This study's 12 months is below that.
Counting every sponsor, half of 73 studies reached it within 30 months; a quarter within 18 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Delta University for Science and Technology