Pleural Effusion DisorderNCT07875764
Predictive Role of Lung Ultrasound in Re-Expansion Pulmonary Edema During Thoracocentesis
A study testing Serial Bedside Lung Ultrasound (LUS) Protocol in people with Pleural Effusion Disorder and Re-expansion Pulmonary Edema, run by Delta University for Science and Technology at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusion Disorder, Re-expansion Pulmonary Edema, Pulmonary Edemas
- What is being tested?
- Serial Bedside Lung Ultrasound (LUS) Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Sep 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged >= 18 years.
- Moderate-to-massive pleural effusion confirmed by clinical and radiological assessment.
- Clinical indication for therapeutic thoracocentesis.
- Ability to provide written informed consent.
Who cannot join
- Active congestive heart failure with established or suspected cardiogenic pulmonary edema.
- Hydropneumothorax or active chest-tube drainage before enrollment.
- Severe uncorrected coagulopathy or clinically significant bleeding diathesis precluding thoracocentesis.
- Baseline hemodynamic instability requiring vasopressor support.
- Requirement for invasive or non-invasive mechanical ventilatory support before the procedure.
- Pregnancy.
- Inability to cooperate with the procedure or refusal to participate.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University Hospitals - Chest Medicine Department
Al Mansurah, Al Dakahlyea, 1234
About this study
Official title: Predictive Role of Lung Ultrasound in Re-Expansion Pulmonary Edema During Thoracocentesis: A Prospective Pilot Study
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.
Read the detailed description
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:
- Lung Aeration Score and its temporal trajectory during fluid removal.
- B-line dynamics, including number, distribution, focal versus diffuse patterns, and development of coalescent B-lines.
- Pleural-line characteristics, including thickness, regularity, and continuity.
- Subpleural abnormalities, particularly newly developed or progressive micro-consolidations.
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.
- Being tested
- Serial Bedside Lung Ultrasound (LUS) Protocol
- Keywords
- Lung Ultrasound, Thoracocentesis, Point-of-Care Ultrasound (POCUS), Pleural Fluid Drainage, B-lines, Lung Aeration Score
- Medical subject headings
- Pleural Effusion, Pulmonary Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serial Bedside Lung Ultrasound (LUS) ProtocolDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| LUS-Guided Thoracocentesis Protocol Arm | Experimental | 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. Receives: Diagnostic Test: Serial Bedside Lung Ultrasound (LUS) Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Drained Pleural Fluid Volume
Total volume of pleural fluid removed from initiation to completion/termination of thoracocentesis.
Measured: 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.
Measured: 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.
Measured: Baseline (T0) to procedure completion (TEnd, approximately 1 to 2 hours).
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From initiation of procedure up to 48 hours post-procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start30 Sep 2025
- Primary completion30 Sep 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural Effusion DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single-arm interventional pilot study implementing a real-time LUS-guided thoracocentesis decision protocol.
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delta University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07875764
- Sponsor's protocol ID
- R.26.09.3875
- Status last verified
- Oct 2026
- First submitted
- 4 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Role of Lung Ultrasound in Re-Expansion Pulmonary Edema During Thoracocentesis: A Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT07875764
- Acronym / sponsor ID
- R.26.09.3875
- Keywords
- Lung Ultrasound, Thoracocentesis, Point-of-Care Ultrasound (POCUS), Pleural Fluid Drainage, B-lines, Lung Aeration Score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Delta University for Science and TechnologyUniversity, hospital or other
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 15 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Lung Aeration Score and its temporal trajectory during fluid removal.
- B-line dynamics, including number, distribution, focal versus diffuse patterns, and development of coalescent B-lines.
- Pleural-line characteristics, including thickness, regularity, and continuity.
- Subpleural abnormalities, particularly newly developed or progressive micro-consolidations.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single-arm interventional pilot study implementing a real-time LUS-guided thoracocentesis decision protocol.
| Arm | Type | Receives |
|---|---|---|
| LUS-Guided Thoracocentesis Protocol Arm | Experimental | Diagnostic Test: Serial Bedside Lung Ultrasound (LUS) ProtocolPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged >= 18 years.
- Moderate-to-massive pleural effusion confirmed by clinical and radiological assessment.
- Clinical indication for therapeutic thoracocentesis.
- Ability to provide written informed consent.
Key exclusion criteria (7 listed)
- Active congestive heart failure with established or suspected cardiogenic pulmonary edema.
- Hydropneumothorax or active chest-tube drainage before enrollment.
- Severe uncorrected coagulopathy or clinically significant bleeding diathesis precluding thoracocentesis.
- Baseline hemodynamic instability requiring vasopressor support.
- Requirement for invasive or non-invasive mechanical ventilatory support before the procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serial Bedside Lung Ultrasound (LUS) ProtocolStandardized 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. | Diagnostic test | LUS-Guided Thoracocentesis Protocol Arm |
Primary outcome
Total Drained Pleural Fluid Volume
Time frame: At procedure completion (up to 2 hours).
Total volume of pleural fluid removed from initiation to completion/termination of thoracocentesis.
Drainage Velocity
Time frame: At procedure completion (up to 2 hours).
The speed of fluid removal calculated as total drained volume divided by the total duration of the procedure.
Change in Lung Aeration Score (LUS) Across Procedural Milestones
Time frame: Baseline (T0) to procedure completion (TEnd, approximately 1 to 2 hours).
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.
4 secondary outcomes
Incidence of Oxygen Saturation Drop Following Thoracocentesis
Time frame: From initiation of procedure up to 48 hours post-procedure.
Requirement for Mechanical Ventilatory Support
Time frame: From initiation of procedure up to 48 hours post-procedure.
Rate of Unplanned Intensive Care Unit (ICU) Admissions
Time frame: From initiation of procedure up to 48 hours post-procedure.
Incidence of Re-Expansion Pulmonary Edema (RPE)
Time frame: From initiation of procedure up to 48 hours post-procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serial Bedside Lung Ultrasound (LUS) Protocol in people with Pleural Effusion Disorder and Re-expansion Pulmonary Edema, run by Delta University for Science and Technology at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Drained Pleural Fluid Volume (time frame: At procedure completion (up to 2 hours).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.