Clinical trial NCT05454215: Mechanical Insufflator/Exsufflator Technique in Children With Neuromuscular Disease
Official title: Mechanical INsufflator/EXsufflator Technique in Paediatric Subjects With Neuromuscular Disease: a Randomised Crossover Comparison of 2 Modes of Application
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuromuscular Diseases in Children
Keywords: Lung function
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2022-07-12
Enrollment: 7
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Single center non-blinded randomized crossover trial
Primary purpose: PREVENTION

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.

Detailed description: At two consecutive regular outpatient clinic visits, each participant will perform a session of the insufflation/exsufflation technique.

Participants will be randomised by a computer-generated code to one of the two sequences (CON-MOD or MOD-CON) using sealed envelopes. The randomisation list will be generated by a study nurse of the Department of Paediatrics who is not a member of the study group.

The randomisation envelope will be opened by the treating physiotherapist immediately before the first treatment session.

Standardised intervention

At randomisation, the measurement belt of the EIT system will be fitted around the chest of the participant. Once correct fit is confirmed, the baseline measurement (T0) will be taken. After the baseline assessment, the participants will perform the conventional (CON) or modified (MOD) insufflator/exsufflator therapy session under supervision of a physiotherapist. In teh investigator's institution a therapy session consists of 5 series of 5 insufflation/exsufflation manoeuvres each (Cough assist E70, Philips Respironics, Hamburg, Germany). Positive and negative pressures will be set at the individual level of each subject.

Measurements Changes in lung volume and ventilation distribution will be assessed by electrical impedance tomography (EIT). These parameters will be obtained five minutes before (T0) and five, ten, twenty, forty and sixty minutes after the treatment session (T1 - T5). Measurements of 3 minutes will be recorded at each time point. Additionally EIT measurements will be performed continuously during the treatment session.

Electrical Impedance Tomography (EIT) is a non-invasive, radiation-free technique for the assessment of spatial and temporal ventilation distribution based on the changes in electrical properties of the tissue during the respiratory cycle. EIT measurements will be performed using a commercially available setup (PulmoVista 500, Draeger, Germany). Image reconstruction will be performed with the GREIT-algorithm using the torso mesh function. \[Adler, 2009\] Relative change in end-expiratory lung impedance (EELI) and the global inhomogeneity (GI) index, a measure of ventilation inhomogeneity, will be calculated using customized software (Matlab® R2021b, The MathWorks Inc., Nattick, MA, USA).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in end-expiratory lung impedance from baseline
timeFrame: 3-5 Minutes
Secondary outcomes:
measure: Change in ventilation distribution from baseline
timeFrame: 3-5 Minutes
measure: Duration of effect
timeFrame: 15-20 minutes
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital
state: BE
Study officials:
affiliation: Inselspital, Bern University Hospital
name: Thomas Riedel, MD
role: STUDY_DIRECTOR
References:
citation: 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.