Does the Coaching Function Improve the Learning of Mechanical In-exsufflation (MI-E) in Paediatric Subjects?

Cough Clinical Trial

— MI-Ecoaching  

Official title:

Does the Coaching Function Improve the Learning of Mechanical In-exsufflation (MI-E) in Paediatric Subjects?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06190431
• Other study ID #: MI-E coaching project
• Status: Recruiting
• Phase: N/A
• Start date: November 20, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Nicolas Audag, PhD
• Phone: 027641621
• Email: nicolas.audag[@]saintluc.uclouvain.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

RATIONALE In the first part, the population will be composed of healthy children, in the second part, the investigators will include children with neuromuscular diseases. The two parts will follow the same process. The hypothesis is that the use of a coaching module (playful visual stimulation) in addition to guidance by a physiotherapist improves the learning and effectiveness of the MI-E compared to guidance alone. The MI-E technique does not represent any documented risk in its use nor in its indication if the contraindications are respected (non-drained pneumothorax, hemoptysis and hemodynamic instability). Coaching modules (playful visual stimulation) have recently become available on MI-E devices. This experiment will allow us to judge their usefulness in teaching the use of MI-E in paediatric patients.

OBJECTIVES 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. In a second phase, the investigators will test the use in children with neuromuscular diseases. For the process (common for the two parts), eligible subjects will be invited to perform, depending on randomization at the intervention 1 (physiotherapist guidance + coaching module) or the intervention 2 (physiotherapist guidance). The learning times, the coughing expiratory flow rate achieved and the synchronization between the subject and the machine will be compared between the two processes.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Airway Clearance Impairment
• Cough
• Neuromuscular Diseases

Intervention

Other:
• Learning the use of an in-exsufflation device with the guidance of a physiotherapist
Learning to use an in-exsufflation device with the guidance of a physiotherapist
• Using the coaching mode
Learning the use of an in-exsufflation device using a coaching mode (playful visual stimulation) in addition to guidance of a physiotherapist

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

References & Publications (5)

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

Outcome

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)