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Efficacy of Non-instrumental Pleural Chest Physiotherapy (KINEPANCH)

Primary Purpose

Infectious Pleural Effusion

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
KRP-NI + KM
KM
Sponsored by
Hôpital NOVO
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infectious Pleural Effusion focused on measuring Non instrumental physiotherapy, Physiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Universitaire AngersRecruiting
  • Hôpital Victor DupuyRecruiting
  • Centre Hospitalier Henri Duffaut - AvignonRecruiting
  • Hôpital de la Cavale BlancheRecruiting
  • Centre Hospitalier de CholetRecruiting
  • Centre Hospitalier Intercommunal - CréteilRecruiting
  • Centre Hospitalier de DunkerqueRecruiting
  • Centre Hospitalier Universitaire de GrenobleRecruiting
  • Groupe Hospitalier de la RochelleRecruiting
  • Hôpital DupuytrenRecruiting
  • Centre Hospitalier de Mont-de-MarsanRecruiting
  • Centre Hospitalier Régional d'OrléansRecruiting
  • Hôpital Bichat - Claude Bernard
  • Centre Hospitalier René DubosRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention KRP-NI + KM

Control KM

Arm Description

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

Realization of mobilization physiotherapy sessions (KM)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.
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.
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.
Measure of quality of life: Respiratory Questionnaire St Georges
Measure of quality of life with the Respiratory Questionnaire St Georges
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
Days of hospitalization
Number of hospitalization days starting from inclusion
Proportions of complications at M3
Early proportions of complications, surgical treatment and death related to the infectious pleural outpouring.
Duration of sick leave
Number of sick days accumulated in patients with a professional activity
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
Opinion of the physiotherapist
Measurement of the opinion and satisfaction of hospital and liberal physiotherapist participating by self-questionnaire

Full Information

First Posted
February 28, 2019
Last Updated
December 19, 2022
Sponsor
Hôpital NOVO
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1. Study Identification

Unique Protocol Identification Number
NCT03861897
Brief Title
Efficacy of Non-instrumental Pleural Chest Physiotherapy
Acronym
KINEPANCH
Official Title
Efficacy of Non-instrumental Pleural Chest Physiotherapy (KRP-NI) in Initial Management of Infectious Pleural Effusion
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 6, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital NOVO

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infectious Pleural Effusion
Keywords
Non instrumental physiotherapy, Physiotherapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention KRP-NI + KM
Arm Type
Experimental
Arm Description
Realization of Non instrumental pleural chest physiotherapy and Mobilization physiotherapy sessions (KRP-NI)
Arm Title
Control KM
Arm Type
Active Comparator
Arm Description
Realization of mobilization physiotherapy sessions (KM)
Intervention Type
Other
Intervention Name(s)
KRP-NI + KM
Intervention Description
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
Intervention Name(s)
KM
Intervention Description
Mobilization physiotherapy (1 session per day except weekend) during the hospitalization. Afterward, if necessary the doctor can prescribe sessions of mobilization physiotherapy(KM).
Primary Outcome Measure Information:
Title
Variation of vital capacity theoretical between the first day of inclusion and J15 or the last day of hospitalization
Description
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.
Time Frame
At 15 days after inclusion or the last day of hospitalization
Secondary Outcome Measure Information:
Title
Variation of vital capacity theoretical at M1,5 and M3
Description
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).
Time Frame
At 3 months
Title
Measures the intensity of the pain: analogue visual scale
Description
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.
Time Frame
At 3 months
Title
Measurement of rest dyspnea rated according to the modified Borg modified scale
Description
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.
Time Frame
At 3 months
Title
Measurement of effort dyspnea rated according the mMRC scale
Description
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.
Time Frame
At 3 months
Title
Measure of quality of life: Respiratory Questionnaire St Georges
Description
Measure of quality of life with the Respiratory Questionnaire St Georges
Time Frame
At one month and half
Title
Analysis of the thoracic scanner
Description
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
Time Frame
At 3 months
Title
Days of hospitalization
Description
Number of hospitalization days starting from inclusion
Time Frame
At 3 months
Title
Proportions of complications at M3
Description
Early proportions of complications, surgical treatment and death related to the infectious pleural outpouring.
Time Frame
At 3 months
Title
Duration of sick leave
Description
Number of sick days accumulated in patients with a professional activity
Time Frame
At 3 months
Title
Follow-up of physiotherapy carried out in the city
Description
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
Time Frame
At 3 months
Title
Opinion of the physiotherapist
Description
Measurement of the opinion and satisfaction of hospital and liberal physiotherapist participating by self-questionnaire
Time Frame
At 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maryline DELATTRE
Phone
0033130754131
Email
maryline.delattre@ght-novo.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Véronique DA COSTA
Phone
0033130755069
Email
veronique.dacosta@ght-novo.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédérique MONTRELAY
Organizational Affiliation
Hôpital NOVO
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire Angers
City
Angers
ZIP/Postal Code
49000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Herveline CRESTIN
Phone
33 6 73 18 95 89
Email
herveline.crestin@chu-angers.fr
Facility Name
Hôpital Victor Dupuy
City
Argenteuil
ZIP/Postal Code
95100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Vion
Phone
33 1 34 23 13 89
Email
christopher.vion@ch-argenteuil.fr
Facility Name
Centre Hospitalier Henri Duffaut - Avignon
City
Avignon
ZIP/Postal Code
84 000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quentin GONNET
Phone
33 6 15 77 80 86
Email
quentingonnet@live.fr
Facility Name
Hôpital de la Cavale Blanche
City
Brest
ZIP/Postal Code
29200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marion Goret
Phone
33 2 98 34 74 15
Ext
41 495
Email
marion.goret@chu-brest.fr
Facility Name
Centre Hospitalier de Cholet
City
Cholet
ZIP/Postal Code
49 300
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cynthia GUEGAN
Phone
33 2 41 49 60 00
Email
cynthia.guegan@ch-cholet.fr
Facility Name
Centre Hospitalier Intercommunal - Créteil
City
Créteil
ZIP/Postal Code
94 000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Géraldine CADUERET
Phone
33 1 57 02 26 77
Email
geraldine.caqueret@chiccreteil.fr
Facility Name
Centre Hospitalier de Dunkerque
City
Dunkerque
ZIP/Postal Code
59240
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lionel Pitau
Phone
33 3 28 28 51 62
Email
lionel_pitau@hotmail.com
Facility Name
Centre Hospitalier Universitaire de Grenoble
City
Grenoble
ZIP/Postal Code
38700
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jordi Fabregat
Phone
33 4 76 76 58 46
Email
jfabregat@chu-grenoble.fr
Facility Name
Groupe Hospitalier de la Rochelle
City
La Rochelle
ZIP/Postal Code
17000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Robert
Phone
33 5 56 45 50 50
Ext
55 554
Email
philippe.terrat@ch-larochelle.fr
Facility Name
Hôpital Dupuytren
City
Limoges
ZIP/Postal Code
87000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique Pejoan
Phone
33 5 55 05 55 55
Ext
49 570
Email
dominique.pejoan@chu-limoges.fr
Facility Name
Centre Hospitalier de Mont-de-Marsan
City
Mont-de-Marsan
ZIP/Postal Code
40024
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria de las Mercedes RODRIGUEZ PEREZ
Phone
33 5 58 05 52 09
Email
mercedesrop@hotmail.com
Facility Name
Centre Hospitalier Régional d'Orléans
City
Orléans
ZIP/Postal Code
45067
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louis-François Birnesser
Phone
33 2 38 51 32 23
Email
louis-francois.birnesser@chr-orleans.fr
Facility Name
Hôpital Bichat - Claude Bernard
City
Paris
ZIP/Postal Code
75018
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonia Hassan
Phone
33 1 40 25 82 37
Email
sonia.hassan@gmail.com
Facility Name
Centre Hospitalier René Dubos
City
Pontoise
ZIP/Postal Code
95303
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maryline Delattre
Phone
+33 (0)1 30 75 41 31
Email
maryline.delattre@ght-novo.fr
First Name & Middle Initial & Last Name & Degree
Véronique Da Costa
Phone
+33 (0)1 30 75 50 69
Email
veronique.dacosta@ght-novo.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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