Thoracic Ultrasound in the Treatment of Pleural Effusion

Study Overview
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Brief Summary
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The main objective of the study is to assess the cost-effectiveness ratio of two management strategies of pleurisy in adults : a strategy by systematic thoracic ultrasound versus a strategy without thoracic ultrasound.

Detailed Description
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Comparison of two management strategies pleural effusions from diagnosis and during the first year of follow up care. Patients are randomized into two groups, each group receiving a different management strategy. Both strategies are compared: Strategy A that involves the systematic use of thoracic ultrasound for the treatment of pleural effusion, treatment and follow up care. It will be possible to have recourse to other tests (such as chest CT) if deemed necessary by the practitioner. Strategy B, which consists of the usual care pleurisy and thus without use of ultrasound: gestures are guided either by chest radiograph or by CT chest as necessary in the treatment and monitoring. A systematic radiographic pleural after each gesture is performed. The management is inspired by the English recommendations currently validated and applied in Anglo-Saxon countries.

Official Title
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Treatment of Pleural Effusion by Routine Thoracic Ultrasound

Conditions
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Pleural Effusion

Intervention / Treatment
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* Procedure: Strategy with thoracic ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients hospitalized or seen in consultation with pleural effusion diagnosed clinically or radiologically whatever be its initial management. Exclusion Criteria: Patient with a neoplasia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Strategy with thoracic ultrasound<br>Use of thoracic ultrasound for the treatment of pleural effusion, treatment and monitoring. Use of other examinations like chest CT if necessary | Procedure: Strategy with thoracic ultrasound<br>* This strategy involves the systematic use of thoracic ultrasound for the treatment of pleural effusion, treatment and follow up care.<br>|
| No Intervention: Strategy without thoracic ultrasound<br>Usual care : without thoracic ultrasound Use of chest radiography or chest CT scan if necessary, as for treatment and monitoring. Usual care: without the use of ultrasound Using either chest radiography or TDM if necessary, as for treatment and monitoring. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The cost-effectiveness ration | Cost estimates will be conducted from the perspective of health insurance. The expenses incurred in the care of patients with pleurisy will be counted in both groups during the follow-up year. The effectiveness will be assessed against the complications of strategy (pneumothorax, respiratory sequelae, surgery, mortality, chest pain sequelae, radiological consequences). | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The duration of hospitalization | number of day of hospitalization between the two strategies | 1 year |