Mechanical Insufflator/Exsufflator Technique in Children With Neuromuscular Disease

NCT05454215 | Completed

• 1 other identifier: MINEX-2
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

In a randomized cross-over design, two different modes of a mechanical insufflator/exsufflator applied to pediatric subjects with neuromuscular disease will be compared with respect to their short term effect on lung function, i.e. lung volume.

Conditions

Neuromuscular Diseases in Children

Keywords

Lung function

Outcome Measures

Primary Outcomes (1)

• Change in end-expiratory lung impedance from baseline

  Change of end-expiratory lung volume estimated by electrical impedance tomography from baseline to immediately after a session of mechanical insufflation/exsufflation.

  3-5 Minutes

Secondary Outcomes (2)

• Change in ventilation distribution from baseline

  3-5 Minutes

• Duration of effect

  15-20 minutes

Study Arms (2)

Conventional settings first, modified settings second

ACTIVE COMPARATOR

The control intervention (CON) is the conventional mode of a commercially available mechanical insufflator/exsufflator. The manoeuvre consists of 5 sets of 5 mechanical insufflations/exsufflations with individual pressure settings. For the study, the same pressure settings will be used as during daily routine. The study intervention (MOD) is a modified mode of a commercially available mechanical insufflator/exsufflator in which the active exsufflation of the last breath of each set will be omitted. The manoeuvre consists of 5 sets of 5 mechanical insufflations/exsufflations with individual pressure settings. For the study, the same pressure settings will be used as during daily routine. This modified mode is already used in daily routine by a minority of subjects with NMD.

Device: Mechanical insufflation/exsufflation conventional; Device: Mechanical insufflation/exsufflation modified

Modified settings first, conventional settings second

EXPERIMENTAL

The study intervention (MOD) is a modified mode of a commercially available mechanical insufflator/exsufflator in which the active exsufflation of the last breath of each set will be omitted. The manoeuvre consists of 5 sets of 5 mechanical insufflations/exsufflations with individual pressure settings. For the study, the same pressure settings will be used as during daily routine. This modified mode is already used in daily routine by a minority of subjects with NMD. The control intervention (CON) is the conventional mode of a commercially available mechanical insufflator/exsufflator. The manoeuvre consists of 5 sets of 5 mechanical insufflations/exsufflations with individual pressure settings. For the study, the same pressure settings will be used as during daily routine.

Device: Mechanical insufflation/exsufflation conventional; Device: Mechanical insufflation/exsufflation modified

Interventions

Mechanical insufflation/exsufflation conventional DEVICE

Conventional settings in a commercially available chest physiotherapy device

Conventional settings first, modified settings second; Modified settings first, conventional settings second

Mechanical insufflation/exsufflation modified DEVICE

Modified settings in a commercially available chest physiotherapy device

Conventional settings first, modified settings second; Modified settings first, conventional settings second

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Confirmed diagnosis of a NMD
• Functional status: non-ambulatory
• Age \>5 years and \< 16 years
• Able to cooperate
• Daily home-use of cough assist as reported by the caregivers
• Written informed consent by the subject/caregiver

You may not qualify if:

• Acute respiratory infection at two consecutive outpatient clinic visits (marked increase in cough, change in sputum amount or colour, fever or malaise)
• Oxygen dependency (defined as need for oxygen to achieve a transcutaneous oxygen saturation of ≥92%)
• Skin lesions at the chest (preventing EIT measurements)
• Chest deformation preventing EIT measurements

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Inselspital

Bern, Canton of Bern, 3010, Switzerland

Location

Related Publications (1)

• Casaulta C, Messerli F, Rodriguez R, Klein A, Riedel T. Changes in ventilation distribution in children with neuromuscular disease using the insufflator/exsufflator technique: an observational study. Sci Rep. 2022 Apr 29;12(1):7009. doi: 10.1038/s41598-022-11190-z.

  PMID: 35488044 BACKGROUND

Study Officials

• Thomas Riedel, MD

  Inselspital, Bern University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single center non-blinded randomized crossover trial

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 12, 2022
• Study Start: February 1, 2023
• Primary Completion: December 7, 2024
• Study Completion: December 20, 2024
• Last Updated: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Available from time of publication for up to two years
• Access Criteria: email: thomas.riedel@insel.ch

Locations

CH (1)