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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 : May 31, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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
Pleural Effusion Procedure: Strategy with thoracic ultrasound Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Pleural Effusion by Routine Thoracic Ultrasound
Study Start Date : July 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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.




Primary Outcome Measures :
  1. 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).



Secondary Outcome Measures :
  1. The duration of hospitalization [ Time Frame: 1 year ]
    number of day of hospitalization between the two strategies


Other Outcome Measures:
  1. The irradiation rate [ Time Frame: 1 year ]
    calculation of irradiation rate between the two strategies

  2. Number of consultations [ Time Frame: 1 year ]
    The number of consultations between the two strategies



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
Contact: Elise NOEL-SAVINA, MD 0567771691 ext +33 noel-savina.e@chu-toulouse.fr
Contact: Alain DIDIER, Professor 0567771830 ext +33 didier.a@chu-toulouse.fr

Locations
France
NOEL-SAVINA Elise Recruiting
Toulouse, Midi Pyrenees, France, 31059
Contact: Elise NOEL-SAVINA, MD    0567771691 ext +33    noel-savina.e@chu-toulouse.fr   
Contact: Alain DIDIER, MD    0567771830 ext +33    didier.a@chu-toulouse.fr   
Principal Investigator: Elise NOEL-SAVINA, MD         
Sub-Investigator: Alain DIDIER, MD         
Sub-Investigator: Gavin PLAT, MD         
Sub-Investigator: Sandrine PONTIER-MARCHANDISE, MD         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Elise NOEL-SAVINA, MD University Hospital, Toulouse

Publications:
Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02505763     History of Changes
Other Study ID Numbers: RC31/14/7418
First Posted: July 22, 2015    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases