NCT02505763

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 22, 2015

Completed
2 years until next milestone

Study Start

First participant enrolled

July 10, 2017

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

November 9, 2020

Status Verified

November 1, 2020

Enrollment Period

4.4 years

First QC Date

July 21, 2015

Last Update Submit

November 6, 2020

Conditions

Pleural Effusion

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The duration of hospitalization

    1 year

Other Outcomes (2)

  • The irradiation rate

    1 year

  • Number of consultations

    1 year

Study Arms (2)

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

Procedure: Strategy with thoracic ultrasound

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.

Interventions

Strategy with thoracic ultrasoundPROCEDURE

This strategy involves the systematic use of thoracic ultrasound for the treatment of pleural effusion, treatment and follow up care.

Strategy with thoracic ultrasound

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients hospitalized or seen in consultation with pleural effusion diagnosed clinically or radiologically whatever be its initial management.

You may not qualify if:

  • Patient with a neoplasia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NOEL-SAVINA Elise

Toulouse, Midi Pyrenees, 31059, France

RECRUITING

Related Publications (5)

  • 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. No abstract available.

    PMID: 20696688BACKGROUND

  • 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.

    PMID: 22700780BACKGROUND

  • 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. doi: 10.1378/chest.123.2.418.

    PMID: 12576360BACKGROUND

  • 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. doi: 10.2214/ajr.154.6.2110724.

    PMID: 2110724BACKGROUND

  • 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.

    PMID: 19255298BACKGROUND

MeSH Terms

Conditions

Pleural Effusion

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Study Officials

  • Elise NOEL-SAVINA, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elise NOEL-SAVINA, MD

CONTACT

0567771691noel-savina.e@chu-toulouse.fr

Alain DIDIER, Professor

CONTACT

0567771830didier.a@chu-toulouse.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2015

First Posted

July 22, 2015

Study Start

July 10, 2017

Primary Completion

December 1, 2021

Study Completion

December 1, 2022

Last Updated

November 9, 2020

Record last verified: 2020-11

Locations

FR(1)