Thoracic Ultrasound in the Treatment of Pleural Effusion

Not Applicable

• Conditions: Pleural Effusion
• Interventions: Procedure: Strategy with thoracic ultrasound

• Registration Number: NCT02505763
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-07-21
• Study First Submitted QC: 2015-07-21
• Study First Posted: 2015-07-22
• Study Start: 2017-07-10
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-06
• Last Update Posted: 2020-11-09
• Primary Completion: 2021-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Strategy with thoracic ultrasound	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
The duration of hospitalization	1 year	number of day of hospitalization between the two strategies

Trial Locations

Locations (1)

NOEL-SAVINA Elise; 🇫🇷 Toulouse, Midi Pyrenees, France