ECHOPLEV: Thoracic Ultrasound in the Treatment of Pleural Effusion
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Strategy with thoracic ultrasound 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
This strategy involves the systematic use of thoracic ultrasound for the treatment of pleural effusion, treatment and follow up care.
|
| No Intervention: Strategy without thoracic ultrasound 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. |
Outcome Measures
Primary Outcome Measures
- The cost-effectiveness ration [1 year]
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).
Secondary Outcome Measures
- The duration of hospitalization [1 year]
number of day of hospitalization between the two strategies
Other Outcome Measures
- The irradiation rate [1 year]
calculation of irradiation rate between the two strategies
- Number of consultations [1 year]
The number of consultations between the two strategies
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | NOEL-SAVINA Elise | Toulouse | Midi Pyrenees | France | 31059 |
Sponsors and Collaborators
- University Hospital, Toulouse
Investigators
- Principal Investigator: Elise NOEL-SAVINA, MD, University Hospital, Toulouse
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- RC31/14/7418