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

NCT06190431 | Unknown DMC

• 1 other identifier: MI-E coaching project
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cough; Airway Clearance Impairment; Neuromuscular Diseases

Keywords

Mechanical In-Exsufflation; Coaching; Cough Assistance; Pediatric

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Peak cough flow measured with the device (L/min)

  During the learning session (max 15 minutes)

• Peak cough flow measured with the device (L/min)

  During the session on the second day (24 hours after the learning session)

• Visual analog scales (VAS) "ease of use" (0-10)

  At the end of the learning session (max 15 minutes)

• Visual analog scales (VAS) "ease of use" (0-10)

  At the end of the session on the second day (24 hours after the learning session)

• Visual analog scales (VAS) "comfort" (0-10)

  At the end of the learning session (max 15 minutes)

Study Arms (2)

Only physiotherapist guidance

ACTIVE COMPARATOR

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

Physiotherapist guidance + coaching module

ACTIVE COMPARATOR

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; Other: Using the coaching mode

Interventions

Learning the use of an in-exsufflation device with the guidance of a physiotherapist OTHER

Learning to use an in-exsufflation device with the guidance of a physiotherapist

Only physiotherapist guidance; Physiotherapist guidance + coaching module

Using the coaching mode OTHER

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

Physiotherapist guidance + coaching module

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 6-12 (F/M)
• Acceptance of consent (child + 2 parents)
• Non-smoker
• Speak and understand French
• Schooling in mainstream education

You may not qualify if:

• 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:
• 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
• Hemodynamic instability
• Current or recent pneumothorax
• Hemoptysis

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques universitaires Saint Luc

Brussels, 1200, Belgium

RECRUITING

Related Publications (5)

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

  PMID: 28546380 BACKGROUND

• 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.

  PMID: 22949331 BACKGROUND

• 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.

  PMID: 36787316 BACKGROUND

• 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.

  PMID: 22730428 BACKGROUND

• 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.

  PMID: 33393110 BACKGROUND

MeSH Terms

Conditions

Cough; Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nervous System Diseases

Study Officials

• Nicolas Audag, PhD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas Audag, PhD

CONTACT

027641621; nicolas.audag@saintluc.uclouvain.be

Gregory Reychler, Pr

CONTACT

027642316; gregory.reychler@saintluc.uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: January 5, 2024
• Study Start: November 20, 2023
• Primary Completion: January 20, 2024
• Study Completion: December 31, 2024
• Last Updated: January 5, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)