Thoracic Ultrasound in the Treatment of Pleural Effusion (ECHOPLEV)
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|ClinicalTrials.gov Identifier: NCT02505763|
Recruitment Status : Recruiting
First Posted : July 22, 2015
Last Update Posted : December 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pleural Effusion||Procedure: Strategy with thoracic ultrasound||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||144 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Pleural Effusion by Routine Thoracic Ultrasound|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2019|
Experimental: Strategy with thoracic ultrasound
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 the use of ultrasound Using either chest radiography or TDM if necessary, as for treatment and monitoring.
- The cost-effectiveness ration [ Time Frame: 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).
- The duration of hospitalization [ Time Frame: 1 year ]number of day of hospitalization between the two strategies
- The irradiation rate [ Time Frame: 1 year ]calculation of irradiation rate between the two strategies
- Number of consultations [ Time Frame: 1 year ]The number of consultations between the two strategies
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02505763
|Contact: Elise NOEL-SAVINA, MD||0567771691 ext +firstname.lastname@example.org|
|Contact: Alain DIDIER, Professor||0567771830 ext +email@example.com|
|Toulouse, Midi Pyrenees, France, 31059|
|Contact: Elise NOEL-SAVINA, MD 0567771691 ext +33 firstname.lastname@example.org|
|Contact: Alain DIDIER, MD 0567771830 ext +33 email@example.com|
|Principal Investigator: Elise NOEL-SAVINA, MD|
|Sub-Investigator: Alain DIDIER, MD|
|Sub-Investigator: Gavin PLAT, MD|
|Sub-Investigator: Sandrine PONTIER-MARCHANDISE, MD|
|Principal Investigator:||Elise NOEL-SAVINA, MD||University Hospital, Toulouse|