Efficacy of Non-instrumental Pleural Chest Physiotherapy

Last updated: December 30, 2024
Sponsor: Hôpital NOVO
Overall Status: Completed

Phase

N/A

Condition

Lung Disease

Pleural Effusion

Treatment

KM

KRP-NI + KM

Clinical Study ID

NCT03861897
CHRD1815
  • Ages > 18
  • All Genders

Study Summary

The main purpose of this study is to assess efficacy of non instrumental pleural chest physiotherapy on the recovery of respiratory function, at hospital discharge or 15 days after beginning the pleural chest physiotherapy, compared to physiotherapy with standard mobilization, in patients with infectious pleural effusion, who have received usual medical treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ≥ eighteen years old

  • to be hospitalized for an infectious pleural outpouring

  • to have a liquid pleural outpouring diagnosed by echography or to scan thoracic

  • presence of a Exudate according to the criteria of Light, to have at least criteria:

  • The ratio of pleural fluid protein to serum protein is greater than 0.5

  • The ratio of pleural fluid Lactate dehydrogenase (LDH) and serum LDH is greaterthan 0.6

  • The rate of pleural fluid LDH is > 2/3 upper limit of normal serum LDH of thelaboratory concerned

  • presence of at least two of the following criteria:

  • fever higher or equal 38°C (100.4°F)

  • thoracic pain

  • purulent sputum

  • purulent pleural effusion at the time of the exploring pleural puncture

  • hearth of crackling to the sounding

  • Inflammatory syndrome (CRP>15 mg/l and/or White blood cell >10 000 /mm3)

  • no known radiological hearth before

  • Having undergone an evacuation gesture going back to less forty-eight hours:evacuation pleural puncture or repeated pleural punctures or pleural drainageallowing the evacuation of at least 100cc of pleural fluid

  • Informed and having given its free, lit and express assent

  • Patients with affiliation to the social security system

Exclusion

Exclusion Criteria:

  • Patient having undergone a thoracotomy or thoracoscopy in the six previous months

  • Patient having a pneumothorax

  • Patient reached of a tuberculosis

  • Patient unable to carry out a measurement of the vital capacity by portablespirometer at the inclusion

  • Pregnant woman or nursing

  • Patient having a life expectancy lower than three months

  • Proven or suspected pleural neoplasia disease

  • Patient hemodynamically unstable

  • Patient having a respiratory insufficiency requiring the introduction of anartificial ventilation

  • Patient carrying a chronic respiratory insufficiency under non-invasive ventilationwith the long course

  • Patient unable to carry out the exercises of physiotherapy (problem of communicationand/or comprehension and/or physical inaptitude)

  • Patient transplanted of a solid body, allograft or autograft of hematopoietic stemcells

  • Patient with a seropositivity for the known HIV and cluster of differentiation 4 (CD4) <250/mm3

Study Design

Total Participants: 82
Treatment Group(s): 2
Primary Treatment: KM
Phase:
Study Start date:
June 06, 2019
Estimated Completion Date:
December 11, 2024

Study Description

Pleural effusions are defined by an abnormal amount of fluid in the pleural space. Those complicating a pneumonia are commonly encountered in pneumology departments, and their number are increasing. If not quickly treated, complications often occur: pleural adhesions, pleural thickening which can lead to a restrictive lung disease, or even to surgery. The average length of stay in hospital of this patients is 15 days. The management of infectious pleural effusion consists of removing the fluid from the pleural space (pleural puncturing or drainage), with or without fibrinolytics, antibiotics, and chest physiotherapy. Chest physiotherapy is often prescribed, but its benefits are largely based on empirical evidence. In the absence of recommendations, chest physiotherapy is done in heterogeneous ways, in France and abroad.

Pleural chest physiotherapy combines postural respiratory exercises, increased ventilation with dynamics expirations, and early inspiratory exercises, resulting in mobilization of pleura and pleural fluid. The hypothesis is that pleural chest physiotherapy thus makes it possible to fight against pleural effusion stagnation, to help resorption of pleural fluid, to limit formation of pleural adhesions and fixed restrictive lung disease. This should improve the recovery of respiratory function, and allow a shorter hospital stay, an improvement of the quality of life, earlier resumption of activities, and a reduction in the risk of complications.

Connect with a study center

  • Centre Hospitalier Universitaire Angers

    Angers, 49000
    France

    Site Not Available

  • Hôpital Victor Dupuy

    Argenteuil, 95100
    France

    Site Not Available

  • Centre Hospitalier Henri Duffaut - Avignon

    Avignon, 84 000
    France

    Site Not Available

  • Hôpital de la Cavale Blanche

    Brest, 29200
    France

    Site Not Available

  • Centre Hospitalier de Cholet

    Cholet, 49 300
    France

    Site Not Available

  • Centre Hospitalier Intercommunal - Créteil

    Créteil, 94 000
    France

    Site Not Available

  • Centre Hospitalier de Dunkerque

    Dunkerque, 59240
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Grenoble

    Grenoble, 38700
    France

    Site Not Available

  • Groupe Hospitalier de la Rochelle

    La Rochelle, 17000
    France

    Site Not Available

  • Hôpital Dupuytren

    Limoges, 87000
    France

    Site Not Available

  • Centre Hospitalier de Mont-de-Marsan

    Mont-de-Marsan, 40024
    France

    Site Not Available

  • Centre Hospitalier Régional d'Orléans

    Orléans, 45067
    France

    Site Not Available

  • Hôpital Bichat - Claude Bernard

    Paris, 75018
    France

    Site Not Available

  • Centre Hospitalier René Dubos

    Pontoise, 95303
    France

    Site Not Available

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