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

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.

Study Overview

• Status: Recruiting
• Conditions: Neuromuscular Diseases; Cough; Airway Clearance Impairment
• Intervention / Treatment: Other: Learning the use of an in-exsufflation device with the guidance of a physiotherapist; Other: Using the coaching mode

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicolas Audag, PhD; Phone Number: 027641621; Email: nicolas.audag@saintluc.uclouvain.be
• Study Contact Backup: Name: Gregory Reychler, Pr; Phone Number: 027642316; Email: gregory.reychler@saintluc.uclouvain.be

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Recruiting
    • Cliniques Universitaires Saint Luc
    • Contact: Nicolas Audag, Phd; Phone Number: 00327641621; Email: nicolas.audag@saintluc.uclouvain.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Only physiotherapist guidance; 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.	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
Active Comparator: Physiotherapist guidance + coaching module; 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.	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; Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Investigators: Principal Investigator: Nicolas Audag, PhD, Cliniques universitaires Saint-Luc

Publications and helpful links

General Publications

• 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.
• Panitch HB. Respiratory Implications of Pediatric Neuromuscular Disease. Respir Care. 2017 Jun;62(6):826-848. doi: 10.4187/respcare.05250.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2023
• Primary Completion (Estimated): January 20, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: December 8, 2023
• First Submitted That Met QC Criteria: January 3, 2024
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Pediatric; Coaching; Mechanical In-Exsufflation; Cough Assistance
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases
• Other Study ID Numbers: MI-E coaching project

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No