COPDMUKROBSNCT05480163
Acoustic and Volumetric Measurements in Order to Objectify Bronchial Congestion in Patients With Obstructive Respiratory Pathologies Within the Framework of Their Management in Respiratory Physiotherapy for Decongestion
A study testing Measurement records in people with COPD, run by Association des Réseaux Bronchiolite at 2 sites in France.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a chronic respiratory disease defined by permanent airway obstruction. In this disease, a large part of the muscular work is taken up by breathing (fight against bronchial, parietal or fibrous resistances of the pulmonary tissue, reduction of the exchange surface)… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- COPD
- What is being tested?
- Measurement records
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- 18 Jun 2022to Aug 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Control group
- Patient with no known respiratory pathology and a normal forced expiratory volume at one second (FEV1) /FVC ratio normal for age and sex (chart).
- COPD group
- Patients diagnosed with COPD, post exacerbations and/or post hospitalisation with chronic congestion
Who cannot join
- Control group
- Smoker or former smoker (less than 6 years of cessation)
- Prolonged or repeated exposure to gases, dusts, fumes, vapours in the context of professional activities
- Respiratory pathology
- Pacemaker or heart battery wearers
- Cognitive disorders that do not allow for informed consent
Show all 25Show fewer
- Prostheses or metallic materials (vascular clip, neuro-stimulator, insulin pump, various implants, etc.)
- Chest pain context
- Spinal orthopaedic disorders not compatible with the device (cypho scoliosis etc...)
- Opposition of the patient
- BMI >30
- History of hospitalization for coronavirus
- COPD group :
- Refusal to transfer image rights
- Haemoptysis
- Pacemaker or heart battery wearers
- Cognitive impairment that does not allow for informed consent
- Prostheses or metallic devices (vascular clip, neuro-stimulator, insulin pump, various implants)
- Presence of oppressive chest pain
- Neurological pathologies (Parkinson's, etc.)
- Paradoxical breathing
- Spinal orthopaedic disorders not compatible with the device (cypho scoliosis etc...)
- Opposition of the patient
- BMI >30
- History of hospitalization for coronavirus
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Physiotherapy practice of Mr TORRES
Annecy
Laurent TORRES
- Recruiting
Physiotherapy practice of Mr. Jean-Charles LAPORTE
Paris
Jean-Charles LAPORTE
About this study
Chronic obstructive pulmonary disease (COPD) is a chronic respiratory disease defined by permanent airway obstruction. In this disease, a large part of the muscular work is taken up by breathing (fight against bronchial, parietal or fibrous resistances of the pulmonary tissue, reduction of the exchange surface), requiring a physiotherapeutic care.
Physiotherapy management of "respiratory rehabilitation" includes 4 items: respiratory therapy for decongestion, muscle strengthening, improvement of endurance and therapeutic education. In this context, the techniques of de-cluttering aim to decrease the hydrodynamic resistance of the bronchial tree. A systematic evaluation of the patient's condition is carried out by the practitioners to assess, at the time of the session, the bronchial congestion. In addition to their knowledge of the history of the patient they are following and the result of the oximetry measurement, practitioners use several indicators to assess the patient's bronchial congestion and define their therapeutic approach: cough, sputum, oximetry and peak expiratory flow, pulmonary auscultation. Sound expertise remains delicate: even the most educated human auditory system is not physiologically capable of detecting some of the relevant information. The current quantification criteria are therefore not very objective, depend on the practitioner's expertise and do not allow recommendations to be made on the conduct of the session during the follow-up of patients. Consequently, the objectification of bronchial congestion is clearly part of the process of improving management. In this context, the MUKROBS project seeks to objectify the bronchial congestion of COPD patients during their management by means of respiratory physiotherapy techniques of de-congestion by means of expiratory flow modulation techniques.
The Sybille device, designed, developed and validated in the framework of a previous project funded by the ANR VirtualChest, allows continuous, non-invasive and simultaneous measurements of sound and displacement information at specific points of the thoracic cage.
Read the detailed description
COPD is a chronic respiratory disease defined by permanent airway obstruction. Epidemiological data are scarce: the prevalence is difficult to estimate because of underdiagnosis and the difficultý to perform respiratory function tests (RFTs) in epidemiological studies. It is estimated at 7.5% in a population over 45 years of age, with the incidence appearing to stabilize in men and increase in women. Furthermore, in 2018, 25.4% of adult patients had daily tobacco use. In 2014, 81,600 individuals were on long-term disability (LTD) for chronic bronchitis without specifics. The 2017 report by the Directorate for Research, Studies, Evaluation and Statistics (DREES) on the health status of the population in France shows that: in 2013, approximately 19,000 deaths were related to COPD, 48% of which were due to the initial cause; the crude mortality rateś related to COPD were 96/100,000 adults aged 45 years or older in men and 41/100,000 in women ; in 2014, the annual number of hospitalizations for COPD exacerbation ranged from 100 000 to 160 000, depending on the indicator; crude hospitalization rates were 31/10 000 in men and 15.4/10 000 in women, with the highest rates (>20%) in the northern and eastern regions of France and in Reunion. Standardized hospitalization rates have increased́ since 2000, by 2% per year in men and 5% per year in women. The average direct costs of COPD increase with the level of severitý of the disease and rise on average from €7,628 per year for the least severe patients to €20,747 per year for patients on oxygen therapy.
In this condition, a large part of the muscular work is taken up by breathing (fight against bronchial, parietal or fibrous resistances of the lung tissue, decrease of the exchange surface), requiring physiotherapeutic management.
The physiotherapeutic treatment "respiratory rehabilitation", includes 4 items: respiratory physiotherapy for decongestion, muscular strengthening, improvement of endurance and therapeutic education. Within this framework, the techniques of de-cluttering are intended to decrease the hydrodynamic resistance of the bronchial tree. A systematic evaluation of the patient's condition is carried out by the practitioners to assess, at the time of the session, the bronchial congestion. In addition to their knowledge of the history of the patient they are following and the result of the oximetry measurement, practitioners rely on several indicators to assess the patient's bronchial congestion and define their therapeutic approach: cough, sputum, oximetry and peak expiratory flow, pulmonary auscultation which provides sound information, and a call maneuver which allows a subjective assessment of the volumes that can be mobilized thanks to haptic information.
Sound expertise remains delicate: even the most educated human auditory system is not physiologically capable of detecting some of the relevant information. Multiple pathological breath sounds are referenced in the literature, for which different classifications exist, based on their frequency characteristics, their sound waveforms and their durations.
As for the haptic evaluation of thoracic compliance, it also requires a strong experience of the practitioner.
The current quantification criteria are therefore not very objective, depend on the practitioner's expertise and do not allow recommendations on the conduct of the session during the follow-up of the patients. Therefore, the objectification of bronchial congestion is clearly part of the improvement of the management of KR (Assess, Anticipate, Prevent, Treat). The design of specific tools dedicated to the quantified monitoring of relevant parameters of the lung condition is of definite interest to achieve these objectives.
In this context, the MUKROBS project seeks to objectivize the bronchial congestion of COPD patients, during their management by respiratory physiotherapy techniques of de-congestion by means of modulation of the expiratory flow.
The Sybille device, designed, developed and validated in the framework of a previous project funded by the ANR VirtualChest, allows continuous, non-invasive and simultaneous measurements of sound and displacement information at specific points of the thoracic cage. The investigators will conduct a measurement campaign in the context of follow-up in private practice. The measurements will be analyzed with numerical methods specifically developed in order to achieve an automatic identification of pathological respiratory sounds. The investigators will also try to localize bronchial obstructions and to correlate them with respiratory volume variations measured before, during and after the management session.
- Conditions
- COPD
- Being tested
- Measurement records
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement recordsOther
Recordings of spirometry, acoustics, movement (chest volumetry) parameters for FVC and LVC exercises.
| Study group | Role | What they receive |
|---|---|---|
| Measurement records in COPD patients | Experimental | 1. The subject is informed of the procedure, his or her rights, and the use of the data collected (including the video recording of the session)
2. Pre-session clinical assessment by the physiotherapist
3. Installation of the Sybille waistcoat on the patient
4. First measurement phase: Recording of spirometry parameters, acoustics, movements (thoracic volumetry) for forced vital capacity (FVC) and LVC manoeuvres.
5. Second phase of measurements:
Treatment: the physiotherapist performs the session in the classical way. Recording of acoustic parameters, movements (thoracic volumetry).
6. Third phase of measurements: Recording of spirometry, acoustics and movement parameters (thoracic volumetry) for FVC and LVC manoeuvres.
7. Removal of measurement devices
8. Post session evaluation by the physiotherapist. Receives: Other: Measurement records |
| Measurement records in control subject | Other | 1. The subject is informed of the procedure, his or her rights, and the use of the data collected (including the video recording of the session)
2. Clinical assessment by the physiotherapist The subject answers the questionnaire
3. Installation of the Sybille waistcoat on the patient
4. Measurement phase: Recording of spirometry, acoustics, movements (thoracic volumetry) for FVC and LVC manoeuvres.
5. Removal of measurement devices Receives: Other: Measurement records |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scoring of respiratory congestion
Comparison of the scoring of respiratory congestion status assessed by expert physiotherapists and by the Sybille device.
Measured: 75 minutes
Secondary outcomes (7)
Respiratory volumes in COPD group
Respiratory volumes, before and after decongestion manoeuvres, obtained by spirometer in the COPD group.
Measured: 75 minutes
Volumes calculated from the displacements
The volumes calculated from the displacements recorded by the Sybille device of 8 points located on the rib cage, before, during and after the decongestion manoeuvres, in the COPD group.
Measured: 75 minutes
Respiratory volumes in control group
Respiratory volumes obtained by the spirometer in the control group.
Measured: 40 minutes
Volumes calculated in control group
The volumes calculated from the displacements recorded by the Sybille device of 8 points located on the rib cage, in the control group.
Measured: 40 minutes
Rates by type of breath sounds
The rates by type of breath sounds before, during and after the de-cluttering manoeuvres from the sounds recorded by the Sybille device, in the COPD group.
Measured: 75 minutes
Haptic sensations and the number and type of pathological breath
The haptic sensations and the number and type of pathological breath sounds recorded during auscultations by the expert physiotherapists, and which are recorded in a questionnaire, for the COPD group
Measured: 75 minutes
Practitioners' treatment strategies
Practitioners' treatment strategies described by Flanagan's critical incident method, in the COPD group.
Measured: 75 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start18 Jun 2022
- Primary completionJul 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association des Réseaux Bronchiolite
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire Système et Matériaux pour la Mécatronique (SYMME)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05480163
- Sponsor's protocol ID
- MUKROBS
- Other IDs
- 2021-A02143-38
- Acronym
- MUKROBS
- Status last verified
- Jul 2022
- First submitted
- 25 Jul 2022
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acoustic and Volumetric Measurements in Order to Objectify Bronchial Congestion in Patients With Obstructive Respiratory Pathologies Within the Framework of Their Management in Respiratory Physiotherapy for Decongestion
- ClinicalTrials.gov ID
- NCT05480163
- Acronym / sponsor ID
- MUKROBS / MUKROBS
- Conditions
- COPD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Association des Réseaux BronchioliteUniversity, hospital or other
- Collaborators
- Laboratoire Système et Matériaux pour la Mécatronique (SYMME)
- Study start
- 18 Jun 2022 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 29 Jul 2022 (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.
Chronic obstructive pulmonary disease (COPD) is a chronic respiratory disease defined by permanent airway obstruction. In this disease, a large part of the muscular work is taken up by breathing (fight against bronchial, parietal or fibrous resistances of the pulmonary tissue, reduction of the exchange surface), requiring a physiotherapeutic care.
Physiotherapy management of "respiratory rehabilitation" includes 4 items: respiratory therapy for decongestion, muscle strengthening, improvement of endurance and therapeutic education. In this context, the techniques of de-cluttering aim to decrease the hydrodynamic resistance of the bronchial tree. A systematic evaluation of the patient's condition is carried out by the practitioners to assess, at the time of the session, the bronchial congestion. In addition to their knowledge of the history of the patient they are following and the result of the oximetry measurement, practitioners use several indicators to assess the patient's bronchial congestion and define their therapeutic approach: cough, sputum, oximetry and peak expiratory flow, pulmonary auscultation. Sound expertise remains delicate: even the most educated human auditory system is not physiologically capable of detecting some of the relevant information. The current quantification criteria are therefore not very objective, depend on the practitioner's expertise and do not allow recommendations to be made on the conduct of the session during the follow-up of patients. Consequently, the objectification of bronchial congestion is clearly part of the process of improving management. In this context, the MUKROBS project seeks to objectify the bronchial congestion of COPD patients during their management by means of respiratory physiotherapy techniques of de-congestion by means of expiratory flow modulation techniques.
The Sybille device, designed, developed and validated in the framework of a previous project funded by the ANR VirtualChest, allows continuous, non-invasive and simultaneous measurements of sound and displacement information at specific points of the thoracic cage.
Detailed description
COPD is a chronic respiratory disease defined by permanent airway obstruction. Epidemiological data are scarce: the prevalence is difficult to estimate because of underdiagnosis and the difficultý to perform respiratory function tests (RFTs) in epidemiological studies. It is estimated at 7.5% in a population over 45 years of age, with the incidence appearing to stabilize in men and increase in women. Furthermore, in 2018, 25.4% of adult patients had daily tobacco use. In 2014, 81,600 individuals were on long-term disability (LTD) for chronic bronchitis without specifics. The 2017 report by the Directorate for Research, Studies, Evaluation and Statistics (DREES) on the health status of the population in France shows that: in 2013, approximately 19,000 deaths were related to COPD, 48% of which were due to the initial cause; the crude mortality rateś related to COPD were 96/100,000 adults aged 45 years or older in men and 41/100,000 in women ; in 2014, the annual number of hospitalizations for COPD exacerbation ranged from 100 000 to 160 000, depending on the indicator; crude hospitalization rates were 31/10 000 in men and 15.4/10 000 in women, with the highest rates (>20%) in the northern and eastern regions of France and in Reunion. Standardized hospitalization rates have increased́ since 2000, by 2% per year in men and 5% per year in women. The average direct costs of COPD increase with the level of severitý of the disease and rise on average from €7,628 per year for the least severe patients to €20,747 per year for patients on oxygen therapy.
In this condition, a large part of the muscular work is taken up by breathing (fight against bronchial, parietal or fibrous resistances of the lung tissue, decrease of the exchange surface), requiring physiotherapeutic management.
The physiotherapeutic treatment "respiratory rehabilitation", includes 4 items: respiratory physiotherapy for decongestion, muscular strengthening, improvement of endurance and therapeutic education. Within this framework, the techniques of de-cluttering are intended to decrease the hydrodynamic resistance of the bronchial tree. A systematic evaluation of the patient's condition is carried out by the practitioners to assess, at the time of the session, the bronchial congestion. In addition to their knowledge of the history of the patient they are following and the result of the oximetry measurement, practitioners rely on several indicators to assess the patient's bronchial congestion and define their therapeutic approach: cough, sputum, oximetry and peak expiratory flow, pulmonary auscultation which provides sound information, and a call maneuver which allows a subjective assessment of the volumes that can be mobilized thanks to haptic information.
Sound expertise remains delicate: even the most educated human auditory system is not physiologically capable of detecting some of the relevant information. Multiple pathological breath sounds are referenced in the literature, for which different classifications exist, based on their frequency characteristics, their sound waveforms and their durations.
As for the haptic evaluation of thoracic compliance, it also requires a strong experience of the practitioner.
The current quantification criteria are therefore not very objective, depend on the practitioner's expertise and do not allow recommendations on the conduct of the session during the follow-up of the patients. Therefore, the objectification of bronchial congestion is clearly part of the improvement of the management of KR (Assess, Anticipate, Prevent, Treat). The design of specific tools dedicated to the quantified monitoring of relevant parameters of the lung condition is of definite interest to achieve these objectives.
In this context, the MUKROBS project seeks to objectivize the bronchial congestion of COPD patients, during their management by respiratory physiotherapy techniques of de-congestion by means of modulation of the expiratory flow.
The Sybille device, designed, developed and validated in the framework of a previous project funded by the ANR VirtualChest, allows continuous, non-invasive and simultaneous measurements of sound and displacement information at specific points of the thoracic cage. The investigators will conduct a measurement campaign in the context of follow-up in private practice. The measurements will be analyzed with numerical methods specifically developed in order to achieve an automatic identification of pathological respiratory sounds. The investigators will also try to localize bronchial obstructions and to correlate them with respiratory volume variations measured before, during and after the management session.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Measurement records in COPD patients | Experimental | Other: Measurement records1. The subject is informed of the procedure, his or her rights, and the use of the data collected (including the video recording of the session) 2. Pre-session clinical assessment by the physiotherapist 3. Installation of the Sybille waistcoat on the patient 4. First measurement phase: Recording of spirometry parameters, acoustics, movements (thoracic volumetry) for forced vital capacity (FVC) and LVC manoeuvres. 5. Second phase of measurements: Treatment: the physiotherapist performs the session in the classical way. Recording of acoustic parameters, movements (thoracic volumetry). 6. Third phase of measurements: Recording of spirometry, acoustics and movement parameters (thoracic volumetry) for FVC and LVC manoeuvres. 7. Removal of measurement devices 8. Post session evaluation by the physiotherapist. |
| Measurement records in control subject | Other | Other: Measurement records1. The subject is informed of the procedure, his or her rights, and the use of the data collected (including the video recording of the session) 2. Clinical assessment by the physiotherapist The subject answers the questionnaire 3. Installation of the Sybille waistcoat on the patient 4. Measurement phase: Recording of spirometry, acoustics, movements (thoracic volumetry) for FVC and LVC manoeuvres. 5. Removal of measurement devices |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Control group
- Patient with no known respiratory pathology and a normal forced expiratory volume at one second (FEV1) /FVC ratio normal for age and sex (chart).
- COPD group
- Patients diagnosed with COPD, post exacerbations and/or post hospitalisation with chronic congestion
Key exclusion criteria (25 listed)
- Control group
- Smoker or former smoker (less than 6 years of cessation)
- Prolonged or repeated exposure to gases, dusts, fumes, vapours in the context of professional activities
- Respiratory pathology
- Pacemaker or heart battery wearers
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 |
|---|---|---|
| Measurement recordsRecordings of spirometry, acoustics, movement (chest volumetry) parameters for FVC and LVC exercises. | Other | Measurement records in COPD patients, Measurement records in control subject |
Primary outcome
Scoring of respiratory congestion
Time frame: 75 minutes
Comparison of the scoring of respiratory congestion status assessed by expert physiotherapists and by the Sybille device.
7 secondary outcomes
Respiratory volumes in COPD group
Time frame: 75 minutes
Volumes calculated from the displacements
Time frame: 75 minutes
Respiratory volumes in control group
Time frame: 40 minutes
Volumes calculated in control group
Time frame: 40 minutes
Rates by type of breath sounds
Time frame: 75 minutes
Haptic sensations and the number and type of pathological breath
Time frame: 75 minutes
Practitioners' treatment strategies
Time frame: 75 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurement records in people with COPD, run by Association des Réseaux Bronchiolite at 2 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 4 inclusion and 25 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: status not confirmed, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Didier EVENOU (0660946700 ext. +33, devenou@orange.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scoring of respiratory congestion (time frame: 75 minutes). 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 29 Jul 2022.