Clinical trial NCT06190431: Does the Coaching Function Improve the Learning of Mechanical In-exsufflation (MI-E) in Paediatric Subjects?
Official title: Does the Coaching Function Improve the Learning of Mechanical In-exsufflation (MI-E) in Paediatric Subjects?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cough
Airway Clearance Impairment
Neuromuscular Diseases
Keywords: Mechanical In-Exsufflation
Coaching
Cough Assistance
Pediatric
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Effectiveness
timeFrame: A the end of the learning session (after maximum 15 minutes)
measure: Effectiveness
timeFrame: A the end of the learning (after maximum 15 minutes).
Secondary outcomes:
measure: Peak cough flow measured with the device (L/min)
timeFrame: During the learning session (max 15 minutes)
measure: Peak cough flow measured with the device (L/min)
timeFrame: During the session on the second day (24 hours after the learning session)
measure: Visual analog scales (VAS) "ease of use" (0-10)
timeFrame: At the end of the learning session (max 15 minutes)
measure: Visual analog scales (VAS) "ease of use" (0-10)
timeFrame: At the end of the session on the second day (24 hours after the learning session)
measure: Visual analog scales (VAS) "comfort" (0-10)
timeFrame: At the end of the learning session (max 15 minutes)
measure: Visual analog scales (VAS) "comfort" (0-10)
timeFrame: At the end of the session on the second day (24 hours after the learning session)
measure: the number of sets (n)
timeFrame: At the end of the session on the second day (24 hours after the learning session)
measure: the time (sec) needed by the subjects to achieve five Quality voluntary coughs
timeFrame: At the end of the session on the second day (24 hours after the learning session)
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint Luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Nicolas Audag, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Panitch HB. Respiratory Implications of Pediatric Neuromuscular Disease. Respir Care. 2017 Jun;62(6):826-848. doi: 10.4187/respcare.05250.
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.
citation: 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.
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.
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.