Skip to main content
Clinical Trials/NCT02505763
NCT02505763UnknownNot Applicable

Treatment of Pleural Effusion by Routine Thoracic Ultrasound

University Hospital, Toulouse1 site in 1 country144 target enrollmentStarted: July 10, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
144
Locations
1
Primary Endpoint
The cost-effectiveness ration

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Strategy with thoracic ultrasound

Experimental
  • Use of thoracic ultrasound for the treatment of pleural effusion, treatment and monitoring.
  • Use of other examinations like chest CT if necessary

Intervention: Strategy with thoracic ultrasound (Procedure)

Strategy without thoracic ultrasound

No Intervention
  • 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.

Outcomes

Primary Outcomes

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 Outcomes

  • The duration of hospitalization(1 year)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials