Cough Clinical Trial
— MI-EcoachingOfficial title:
Does the Coaching Function Improve the Learning of Mechanical In-exsufflation (MI-E) in Paediatric Subjects?
The use of mechanical insufflation-exsufflation (MI-E) in children with neuromuscular diseases (NMD) is recommended by international guidelines and societies and well documented. Many authors have shown that MI-E is safe and effective for airway clearance and has a significant benefit in reducing the duration of the airway clearance session in children with respiratory infections and atelectasis or in the postoperative period. However, its use in paediatrics is still poorly supervised and learning the technique is too often therapist- and/or patient-dependent. The use of a protocol or means of help to guide the initiation and learning of MI-E would allow better use, better adaptation of the settings and potentially better compliance with the treatment. The aim of this study is to test whether the use of a coaching module (playful visual stimulation) in addition to guidance by a physiotherapist improves the learning and effectiveness of the technique compared to guidance alone.This randomized controlled study will first include healthy children, aged 6 to 12 years, with no history or recent respiratory infection affecting lung function or other chronic diseases. In a second phase, the investigators will test the use of the learning process in children with neuromuscular diseases. The investigators hope that the results of this study will provide a better framework for the learning and effectiveness of MI-E. Furthermore, if the results are positive, this will allow better support for the use of MI-E in chronic treatments and help to ensure that this costly treatment for hospitals and public health is used efficiently.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 31, 2024 |
Est. primary completion date | January 20, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years to 12 Years |
Eligibility | Part 1: - Inclusion criteria - Age 6-12 (F/M) - Acceptance of consent (child + 2 parents) - Non-smoker - Speak and understand French - Schooling in mainstream education - Exclusion criteria - Comorbidities: congenital heart disease, chronic lung disease, immune deficiency, neuromuscular disease, neurological disease or multiple disabilities - History or clinical signs of disease affecting lung function, recent lung infection, spinal or thoracic deformity. Part 2: - Inclusion criteria - Age 6-12 (F/M) - Acceptance of consent (child + 2 parents) - Non-smoker - Speak and understand French - Patient with a neuromuscular disease - Able to perform the MI-E maneuver - Exclusion criteria - Hemodynamic instability - Current or recent pneumothorax - Hemoptysis |
Country | Name | City | State |
---|---|---|---|
Belgium | Cliniques universitaires Saint Luc | Brussels |
Lead Sponsor | Collaborator |
---|---|
Cliniques universitaires Saint-Luc- Université Catholique de Louvain |
Belgium,
Hov B, Andersen T, Toussaint M, Mikalsen IB, Vollsaeter M, Markussen H, Indrekvam S, Hovland V. User-perceived impact of long-term mechanical assisted cough in paediatric neurodisability. Dev Med Child Neurol. 2023 May;65(5):655-663. doi: 10.1111/dmcn.15543. Epub 2023 Feb 14. — View Citation
Hov B, Andersen T, Toussaint M, Vollsaeter M, Mikalsen IB, Indrekvam S, Hovland V. Prevalence of long-term mechanical insufflation-exsufflation in children with neurological conditions: a population-based study. Dev Med Child Neurol. 2021 May;63(5):537-544. doi: 10.1111/dmcn.14797. Epub 2021 Jan 3. — View Citation
Hull J, Aniapravan R, Chan E, Chatwin M, Forton J, Gallagher J, Gibson N, Gordon J, Hughes I, McCulloch R, Russell RR, Simonds A. British Thoracic Society guideline for respiratory management of children with neuromuscular weakness. Thorax. 2012 Jul;67 Suppl 1:i1-40. doi: 10.1136/thoraxjnl-2012-201964. No abstract available. — View Citation
Miske LJ, McDonough JM, Weiner DJ, Panitch HB. Changes in gastric pressure and volume during mechanical in-exsufflation. Pediatr Pulmonol. 2013 Aug;48(8):824-9. doi: 10.1002/ppul.22671. Epub 2012 Sep 4. — View Citation
Panitch HB. Respiratory Implications of Pediatric Neuromuscular Disease. Respir Care. 2017 Jun;62(6):826-848. doi: 10.4187/respcare.05250. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effectiveness | The investigators will measure the number of sets (n) needed by the subjects to achieve five quality voluntary coughs during the learning session. | A the end of the learning session (after maximum 15 minutes) | |
Primary | Effectiveness | The investigators will measure the time needed (sec) by the subjects to achieve five quality voluntary coughs during the learning session. | A the end of the learning (after maximum 15 minutes). | |
Secondary | Peak cough flow measured with the device (L/min) | The peak cough flow reached with the In-exsufflation device will be reported | During the learning session (max 15 minutes) | |
Secondary | Peak cough flow measured with the device (L/min) | The peak cough flow reached with the In-exsufflation device will be reported | During the session on the second day (24 hours after the learning session) | |
Secondary | Visual analog scales (VAS) "ease of use" (0-10) | Children will be assessed about the ease of the learning | At the end of the learning session (max 15 minutes) | |
Secondary | Visual analog scales (VAS) "ease of use" (0-10) | Children will be assessed about the ease of the learning | At the end of the session on the second day (24 hours after the learning session) | |
Secondary | Visual analog scales (VAS) "comfort" (0-10) | Children will be assessed about the comfort of the procedure | At the end of the learning session (max 15 minutes) | |
Secondary | Visual analog scales (VAS) "comfort" (0-10) | Children will be assessed about the comfort of the procedure | At the end of the session on the second day (24 hours after the learning session) | |
Secondary | the number of sets (n) | The investigators will measure the number of sets (n) needed by the subjects to achieve five Quality voluntary coughs one day after the first session. | At the end of the session on the second day (24 hours after the learning session) | |
Secondary | the time (sec) needed by the subjects to achieve five Quality voluntary coughs | The investigators will measure the time (sec) needed by the subjects to achieve five Quality voluntary coughs one day after the learning session. | At the end of the session on the second day (24 hours after the learning session) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00116337 -
Spinal Cord Stimulation to Restore Cough
|
N/A | |
Not yet recruiting |
NCT04064333 -
Slow-Stream Expiratory Muscle Strength Training for Veterans With Dysphagia Living in Long-term Care
|
N/A | |
Recruiting |
NCT02482818 -
Efficacy of Pregabalin on Chronic Cough
|
Phase 1/Phase 2 | |
Terminated |
NCT02269761 -
Chest Ultrasound of ER Patients With Cough or SOB
|
||
Active, not recruiting |
NCT02065440 -
The Effect of Ebastine/Pseudoephedrine on Subacute Cough
|
N/A | |
Completed |
NCT01071161 -
The Effect of Azithromycin in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Chronic Productive Cough
|
Phase 3 | |
Terminated |
NCT00668317 -
Bronchial Hyper-responsiveness in Reflux Cough
|
Phase 3 | |
Completed |
NCT00353951 -
An Observational Study of Cough / Lower Respiratory Tract Infection (LRTI) in Primary Care
|
N/A | |
Completed |
NCT00127686 -
Effect of Honey and Dextromethorphan on Nocturnal Cough and Sleep
|
Phase 1 | |
Completed |
NCT00287339 -
The Utility of Nexium in Chronic Cough and Reflux Disease
|
Phase 4 | |
Recruiting |
NCT05115097 -
AI Evaluation of COVID-19 Sounds (AI-EChOS)
|
||
Recruiting |
NCT04457011 -
Efficacy and Safety of Susu Zhike Granules for Treating Acute Cough Due to Common Cold With Cold-cough Syndrome in Children
|
Phase 2 | |
Recruiting |
NCT05042063 -
Acoustic Cough Monitoring for the Management of Patients With Known Respiratory Disease
|
||
Recruiting |
NCT03922373 -
A Study of Benzonatate Soft Capsule in Chinese Healthy Subjects
|
Phase 1 | |
Completed |
NCT05812209 -
Stellate Ganglion Block to Treat Long COVID 19 Case Series
|
||
Recruiting |
NCT04767074 -
A Non-pharmacological Cough Control Therapy
|
N/A | |
Recruiting |
NCT05570539 -
Assessment of the Pharmacokinetics of BLU-5937 Extended Release Prototypes and a BLU-5937 Immediate Release Reference Formulation
|
Phase 1 | |
Completed |
NCT03999203 -
A Cross-sectional Study to Measure Cough in Severe Asthma
|
N/A | |
Active, not recruiting |
NCT05479929 -
Work of Breathing Assessment in Triage Scale
|
||
Recruiting |
NCT02495571 -
Assessment of Voluntary and Reflex Cough in Patients With ALS
|
N/A |