Efficacy of Non-instrumental Pleural Chest Physiotherapy

NCT ID: NCT03861897

Last Updated: 2024-12-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-06
• Study Completion Date: 2024-12-11

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.

Conditions

Infectious Pleural Effusion

Keywords

Non instrumental physiotherapy; Physiotherapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Intervention KRP-NI + KM

Realization of Non instrumental pleural chest physiotherapy and Mobilization physiotherapy sessions (KRP-NI)

Group Type: EXPERIMENTAL

KRP-NI + KM

Intervention Type: OTHER

Non instrumental pleural chest physiotherapy (KRP-NI), 2 sessions a day on weekdays and 1 session a day on weekends and mobilization physiotherapy (KM), 1 session per day except weekend during the hospitalization. The combination of the two physiotherapy is KRP-NI + KM. Afterward, 3 sessions per week, renewable until M3 of non instrumental pleural respiratory physiotherapy. If necessary the doctor can prescribe sessions of mobilization physiotherapy

Control KM

Realization of mobilization physiotherapy sessions (KM)

Group Type: ACTIVE_COMPARATOR

KM

Intervention Type: OTHER

Mobilization physiotherapy (1 session per day except weekend) during the hospitalization. Afterward, if necessary the doctor can prescribe sessions of mobilization physiotherapy(KM).

Interventions

KRP-NI + KM

Non instrumental pleural chest physiotherapy (KRP-NI), 2 sessions a day on weekdays and 1 session a day on weekends and mobilization physiotherapy (KM), 1 session per day except weekend during the hospitalization. The combination of the two physiotherapy is KRP-NI + KM. Afterward, 3 sessions per week, renewable until M3 of non instrumental pleural respiratory physiotherapy. If necessary the doctor can prescribe sessions of mobilization physiotherapy

Intervention Type: OTHER

KM

Mobilization physiotherapy (1 session per day except weekend) during the hospitalization. Afterward, if necessary the doctor can prescribe sessions of mobilization physiotherapy(KM).

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hôpital NOVO

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frédérique MONTRELAY

Role: PRINCIPAL_INVESTIGATOR

Hôpital NOVO

Locations

Centre Hospitalier Universitaire Angers

Angers, , France

Hôpital Victor Dupuy

Argenteuil, , France

Hôpital de la Cavale Blanche

Brest, , France

Centre Hospitalier de Cholet

Cholet, , France

Centre Hospitalier Intercommunal - Créteil

Créteil, , France

Centre Hospitalier de Dunkerque

Dunkirk, , France

Centre Hospitalier Universitaire de Grenoble

Grenoble, , France

Groupe Hospitalier de la Rochelle

La Rochelle, , France

Hôpital Dupuytren

Limoges, , France

Centre Hospitalier Régional d'Orléans

Orléans, , France

Centre Hospitalier René Dubos

Pontoise, , France

Countries

France

Other Identifiers

CHRD1815

Identifier Type: -

Identifier Source: org_study_id