Thoracic Ultrasound in the Treatment of Pleural Effusion

Pleural Effusion Clinical Trial

— ECHOPLEV  

Official title:

Treatment of Pleural Effusion by Routine Thoracic Ultrasound

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02505763
• Other study ID #: RC31/14/7418
• Status: Recruiting
• Phase: N/A
• Start date: July 10, 2017
• Est. completion date: December 2022

Study information

• Verified date: November 2020
• Source: University Hospital, Toulouse
• Contact: Elise NOEL-SAVINA, MD
• Phone: 0567771691
• Email: noel-savina.e[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: December 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pleural Effusion

Intervention

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.

Locations

Country	Name	City	State
France	NOEL-SAVINA Elise	Toulouse	Midi Pyrenees

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The irradiation rate	calculation of irradiation rate between the two strategies	1 year
Other	Number of consultations	The number of consultations between the two strategies	1 year
Primary	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	The duration of hospitalization	number of day of hospitalization between the two strategies	1 year