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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Strategy with thoracic ultrasound | Experimental |
|
|
| Strategy without thoracic ultrasound | No Intervention |
Usual care: without the use of ultrasound Using either chest radiography or TDM if necessary, as for treatment and monitoring. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Strategy with thoracic ultrasound | Procedure | This strategy involves the systematic use of thoracic ultrasound for the treatment of pleural effusion, treatment and follow up care. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The duration of hospitalization | number of day of hospitalization between the two strategies | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| The irradiation rate | calculation of irradiation rate between the two strategies | 1 year |
| Number of consultations | The number of consultations between the two strategies |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elise NOEL-SAVINA, MD | Contact | 0567771691 | +33 | noel-savina.e@chu-toulouse.fr |
| Alain DIDIER, Professor | Contact | 0567771830 | +33 | didier.a@chu-toulouse.fr |
| Name | Affiliation | Role |
|---|---|---|
| Elise NOEL-SAVINA, MD | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NOEL-SAVINA Elise | Recruiting | Toulouse | Midi Pyrenees | 31059 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20696688 | Background | Havelock T, Teoh R, Laws D, Gleeson F; BTS Pleural Disease Guideline Group. Pleural procedures and thoracic ultrasound: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii61-76. doi: 10.1136/thx.2010.137026. No abstract available. | |
| 22700780 | Background | Reissig A, Copetti R, Mathis G, Mempel C, Schuler A, Zechner P, Aliberti S, Neumann R, Kroegel C, Hoyer H. Lung ultrasound in the diagnosis and follow-up of community-acquired pneumonia: a prospective, multicenter, diagnostic accuracy study. Chest. 2012 Oct;142(4):965-972. doi: 10.1378/chest.12-0364. |
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| ID | Term |
|---|---|
| D010996 | Pleural Effusion |
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
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| 1 year |
| 12576360 | Background | Jones PW, Moyers JP, Rogers JT, Rodriguez RM, Lee YC, Light RW. Ultrasound-guided thoracentesis: is it a safer method? Chest. 2003 Feb;123(2):418-23. doi: 10.1378/chest.123.2.418. |
| 2110724 | Background | Ikezoe J, Morimoto S, Arisawa J, Takashima S, Kozuka T, Nakahara K. Percutaneous biopsy of thoracic lesions: value of sonography for needle guidance. AJR Am J Roentgenol. 1990 Jun;154(6):1181-5. doi: 10.2214/ajr.154.6.2110724. |
| 19255298 | Background | Chen HJ, Yu YH, Tu CY, Chen CH, Hsia TC, Tsai KD, Shih CM, Hsu WH. Ultrasound in peripheral pulmonary air-fluid lesions. Color Doppler imaging as an aid in differentiating empyema and abscess. Chest. 2009 Jun;135(6):1426-1432. doi: 10.1378/chest.08-2188. Epub 2009 Mar 2. |