Infectious Pleural EffusionKINEPANCHNCT03861897
Efficacy of Non-instrumental Pleural Chest Physiotherapy
A study testing KRP-NI + KM and KM in people with Infectious Pleural Effusion, run by Hôpital NOVO at 11 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infectious Pleural Effusion
- What is being tested?
- KRP-NI + KM and KM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 11 sitesFrance
- Study dates
- 6 Jun 2019to 11 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Centre Hospitalier Universitaire Angers
Angers, 49000
Hôpital Victor Dupuy
Argenteuil, 95100
Hôpital de la Cavale Blanche
Brest, 29200
Centre Hospitalier de Cholet
Cholet, 49 300
Centre Hospitalier Intercommunal - Créteil
Créteil, 94 000
Centre Hospitalier de Dunkerque
Dunkirk, 59240
Centre Hospitalier Universitaire de Grenoble
Grenoble, 38700
Groupe Hospitalier de la Rochelle
La Rochelle, 17000
Hôpital Dupuytren
Limoges, 87000
Centre Hospitalier Régional d'Orléans
Orléans, 45067
Centre Hospitalier René Dubos
Pontoise, 95303
About this study
Official title: Efficacy of Non-instrumental Pleural Chest Physiotherapy (KRP-NI) in Initial Management of Infectious Pleural Effusion
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.
Read the 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
- Being tested
- KRP-NI + KM, KM
- Keywords
- Non instrumental physiotherapy, Physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KRP-NI + KMOther
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
KMOther
Mobilization physiotherapy (1 session per day except weekend) during the hospitalization. Afterward, if necessary the doctor can prescribe sessions of mobilization physiotherapy(KM).
| Study group | Role | What they receive |
|---|---|---|
| Intervention KRP-NI + KM | Experimental | Realization of Non instrumental pleural chest physiotherapy and Mobilization physiotherapy sessions (KRP-NI) Receives: Other: KRP-NI + KM |
| Control KM | Active comparator | Realization of mobilization physiotherapy sessions (KM) Receives: Other: KM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 15 days after inclusion or the last day of hospitalization
Secondary outcomes (11)
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).
Measured: At 3 months
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.
Measured: At 3 months
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.
Measured: At 3 months
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.
Measured: At 3 months
Measure of quality of life: Respiratory Questionnaire St Georges
Measure of quality of life with the Respiratory Questionnaire St Georges
Measured: At one month and half
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
Measured: At 3 months
Days of hospitalization
Number of hospitalization days starting from inclusion
Measured: At 3 months
Proportions of complications at M3
Early proportions of complications, surgical treatment and death related to the infectious pleural outpouring.
Measured: At 3 months
Duration of sick leave
Number of sick days accumulated in patients with a professional activity
Measured: At 3 months
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
Measured: At 3 months
Opinion of the physiotherapist
Measurement of the opinion and satisfaction of hospital and liberal physiotherapist participating by self-questionnaire
Measured: At 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start6 Jun 2019
- Primary completion23 Sep 2024
- Study completion11 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious Pleural EffusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédérique MONTRELAY, Principal investigator, Hôpital NOVO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03861897
- Sponsor's protocol ID
- CHRD1815
- Acronym
- KINEPANCH
- Status last verified
- Dec 2024
- First submitted
- 28 Feb 2019
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Non-instrumental Pleural Chest Physiotherapy (KRP-NI) in Initial Management of Infectious Pleural Effusion
- ClinicalTrials.gov ID
- NCT03861897
- Acronym / sponsor ID
- KINEPANCH / CHRD1815
- Conditions
- Infectious Pleural Effusion
- Keywords
- Non instrumental physiotherapy, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- 6 Jun 2019 (actual)
- Primary completion
- 23 Sep 2024 (actual)
- Study completion
- 11 Dec 2024 (actual)
- First posted
- 4 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention KRP-NI + KM | Experimental | Other: KRP-NI + KMRealization of Non instrumental pleural chest physiotherapy and Mobilization physiotherapy sessions (KRP-NI) |
| Control KM | Active comparator | Other: KMRealization of mobilization physiotherapy sessions (KM) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- ≥ 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:
- presence of at least two of the following criteria:
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KRP-NI + KMNon 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 | Other | Intervention KRP-NI + KM |
| KMMobilization physiotherapy (1 session per day except weekend) during the hospitalization. Afterward, if necessary the doctor can prescribe sessions of mobilization physiotherapy(KM). | Other | Control KM |
Primary outcome
Variation of vital capacity theoretical between the first day of inclusion and J15 or the last day of hospitalization
Time frame: At 15 days after inclusion 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.
11 secondary outcomes
Variation of vital capacity theoretical at M1,5 and M3
Time frame: At 3 months
Measures the intensity of the pain: analogue visual scale
Time frame: At 3 months
Measurement of rest dyspnea rated according to the modified Borg modified scale
Time frame: At 3 months
Measurement of effort dyspnea rated according the mMRC scale
Time frame: At 3 months
Measure of quality of life: Respiratory Questionnaire St Georges
Time frame: At one month and half
Analysis of the thoracic scanner
Time frame: At 3 months
Days of hospitalization
Time frame: At 3 months
Proportions of complications at M3
Time frame: At 3 months
Duration of sick leave
Time frame: At 3 months
Follow-up of physiotherapy carried out in the city
Time frame: At 3 months
Opinion of the physiotherapist
Time frame: At 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frédérique MONTRELAY principal investigator
Hôpital NOVO
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KRP-NI + KM and KM in people with Infectious Pleural Effusion, run by Hôpital NOVO at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of vital capacity theoretical between the first day of inclusion and J15 or the last day of hospitalization (time frame: At 15 days after inclusion or the last day of hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.