Efficacy of Non-instrumental Pleural Chest Physiotherapy

Infectious Pleural Effusion Clinical Trial

— KINEPANCH  

Official title:

Efficacy of Non-instrumental Pleural Chest Physiotherapy (KRP-NI) in Initial Management of Infectious Pleural Effusion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03861897
• Other study ID #: CHRD1815
• Status: Recruiting
• Phase: N/A
• Start date: June 6, 2019
• Est. completion date: March 2025

Study information

• Verified date: January 2024
• Source: Hôpital NOVO
• Contact: Maryline DELATTRE
• Phone: 0033130754131
• Email: maryline.delattre[@]ght-novo.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: March 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Infectious Pleural Effusion
• Pleural Effusion

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire Angers	Angers
France	Hôpital Victor Dupuy	Argenteuil
France	Centre Hospitalier Henri Duffaut - Avignon	Avignon
France	Hôpital de la Cavale Blanche	Brest
France	Centre Hospitalier de Cholet	Cholet
France	Centre Hospitalier Intercommunal - Créteil	Créteil
France	Centre Hospitalier de Dunkerque	Dunkerque
France	Centre Hospitalier Universitaire de Grenoble	Grenoble
France	Groupe Hospitalier de la Rochelle	La Rochelle
France	Hôpital Dupuytren	Limoges
France	Centre Hospitalier de Mont-de-Marsan	Mont-de-Marsan
France	Centre Hospitalier Régional d'Orléans	Orléans
France	Hôpital Bichat - Claude Bernard	Paris
France	Centre Hospitalier René Dubos	Pontoise

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital NOVO

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation of vital capacity theoretical between the first day of inclusion and J15 or the last day of hospitalization	The Primary Outcome Measure is the variation of the percentage of vital capacity theoretical between the first day of inclusion and J15 or the last day of hospitalization using a portable spirometer (Spirobank II basic).; Realized by an appraiser not being aware of the arm of randomization.	At 15 days after inclusion or the last day of hospitalization
Secondary	Variation of vital capacity theoretical at M1,5 and M3	The variation of the percentage of vital capacity theoretical between the first day of inclusion and a month and half afterwards and between the first day of inclusion and three months afterwards using a portable spirometer (Spirobank II basic).	At 3 months
Secondary	Measures the intensity of the pain: analogue visual scale	Intensity of the pain with an analogue visual scale (AVS) at J15 or the last day of hospitalization, at one month and half after the first day of inclusion and at three months.; The score is between 0 and 10. 0 is the best value (No pain) and 10 the worst (Maximum pain imaginable).; Realized by an appraiser not being aware of the arm of randomization.	At 3 months
Secondary	Measurement of rest dyspnea rated according to the modified Borg modified scale	Measurement of the dyspnea of rest according to the scale of Borg modified at J15 or the last day of hospitalization, at one month and half after the first day of inclusion and at three months. The score is between 0 and 10. 0 is the best value (No shortness of breath) and 10 the worst (Maximum breathlessness).; Realized by an appraiser not being aware of the arm of randomization.	At 3 months
Secondary	Measurement of effort dyspnea rated according the mMRC scale	Measurement of effort dyspnea rated according the Medical Research Council scale (mMRC) at J15 or the last day of hospitalization, at one month and half after the first day of inclusion and at three months.he score is between 0 and 4. 0 is the best value and 4 the worst.; Realized by an appraiser not being aware of the arm of randomization.	At 3 months
Secondary	Measure of quality of life: Respiratory Questionnaire St Georges	Measure of quality of life with the Respiratory Questionnaire St Georges	At one month and half
Secondary	Analysis of the thoracic scanner	Centralized review of thoracic Scanner made at 3 months by radiologist who does not know the arm.; Analysis of pleural pockets number and the maximum thickness of the pleural	At 3 months
Secondary	Days of hospitalization	Number of hospitalization days starting from inclusion	At 3 months
Secondary	Proportions of complications at M3	Early proportions of complications, surgical treatment and death related to the infectious pleural outpouring.	At 3 months
Secondary	Duration of sick leave	Number of sick days accumulated in patients with a professional activity	At 3 months
Secondary	Follow-up of physiotherapy carried out in the city	For the intervention group : the number, the frequency and duration of the meetings of pleural chest physiotherapy carried out in a liberal physiotherapist and the use or not of an instrumental help	At 3 months
Secondary	Opinion of the physiotherapist	Measurement of the opinion and satisfaction of hospital and liberal physiotherapist participating by self-questionnaire	At 3 months