Clinical trial NCT03861897: Efficacy of Non-instrumental Pleural Chest Physiotherapy
Official title: Efficacy of Non-instrumental Pleural Chest Physiotherapy (KRP-NI) in Initial Management of Infectious Pleural Effusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infectious Pleural Effusion
Keywords: Non instrumental physiotherapy
Physiotherapy
Lead sponsor: Hôpital NOVO
Sponsor class: OTHER
First posted: 2019-03-04
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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 greater than 0.6
  * The rate of pleural fluid LDH is \> 2/3 upper limit of normal serum LDH of the laboratory 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 drainage allowing 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 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 portable spirometer 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 an artificial ventilation
* Patient carrying a chronic respiratory insufficiency under non-invasive ventilation with the long course
* Patient unable to carry out the exercises of physiotherapy (problem of communication and/or comprehension and/or physical inaptitude)
* Patient transplanted of a solid body, allograft or autograft of hematopoietic stem cells
* Patient with a seropositivity for the known HIV and cluster of differentiation 4 (CD4) \<250/mm3

Primary outcomes:
measure: Variation of vital capacity theoretical between the first day of inclusion and J15 or the last day of hospitalization
timeFrame: At 15 days after inclusion or the last day of hospitalization
Secondary outcomes:
measure: Variation of vital capacity theoretical at M1,5 and M3
timeFrame: At 3 months
measure: Measures the intensity of the pain: analogue visual scale
timeFrame: At 3 months
measure: Measurement of rest dyspnea rated according to the modified Borg modified scale
timeFrame: At 3 months
measure: Measurement of effort dyspnea rated according the mMRC scale
timeFrame: At 3 months
measure: Measure of quality of life: Respiratory Questionnaire St Georges
timeFrame: At one month and half
measure: Analysis of the thoracic scanner
timeFrame: At 3 months
measure: Days of hospitalization
timeFrame: At 3 months
measure: Proportions of complications at M3
timeFrame: At 3 months
measure: Duration of sick leave
timeFrame: At 3 months
measure: Follow-up of physiotherapy carried out in the city
timeFrame: At 3 months
measure: Opinion of the physiotherapist
timeFrame: At 3 months
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre Hospitalier Universitaire Angers
city: Argenteuil
country: France
facility: Hôpital Victor Dupuy
city: Brest
country: France
facility: Hôpital de la Cavale Blanche
city: Cholet
country: France
facility: Centre Hospitalier de Cholet
city: Créteil
country: France
facility: Centre Hospitalier Intercommunal - Créteil
city: Dunkerque
country: France
facility: Centre Hospitalier de Dunkerque
city: Grenoble
country: France
facility: Centre Hospitalier Universitaire de Grenoble
city: La Rochelle
country: France
facility: Groupe Hospitalier de la Rochelle
city: Limoges
country: France
facility: Hôpital Dupuytren
city: Orléans
country: France
facility: Centre Hospitalier Régional d'Orléans
city: Pontoise
country: France
facility: Centre Hospitalier René Dubos
Study officials:
affiliation: Hôpital NOVO
name: Frédérique MONTRELAY
role: PRINCIPAL_INVESTIGATOR
References: