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Mechanical Insufflator/Exsufflator Technique in Children With Neuromuscular Disease (MINEX-2)

Primary Purpose

Neuromuscular Diseases in Children

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Mechanical insufflation/exsufflation conventional
Mechanical insufflation/exsufflation modified
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neuromuscular Diseases in Children focused on measuring Lung function

Eligibility Criteria

5 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • InselspitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional settings first, modified settings second

Modified settings first, conventional settings second

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in ventilation distribution from baseline
Differences in ventilation distribution assessed with electrical impedance tomography from baseline to immediately after a session of mechanical insufflation/exsufflation.
Duration of effect
Duration of the postulated effect on lung volume assessed by electrical impedance tomography.

Full Information

First Posted
July 6, 2022
Last Updated
March 7, 2023
Sponsor
Insel Gruppe AG, University Hospital Bern
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1. Study Identification

Unique Protocol Identification Number
NCT05454215
Brief Title
Mechanical Insufflator/Exsufflator Technique in Children With Neuromuscular Disease
Acronym
MINEX-2
Official Title
Mechanical INsufflator/EXsufflator Technique in Paediatric Subjects With Neuromuscular Disease: a Randomised Crossover Comparison of 2 Modes of Application
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromuscular Diseases in Children
Keywords
Lung function

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Single center non-blinded randomized crossover trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional settings first, modified settings second
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Modified settings first, conventional settings second
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Mechanical insufflation/exsufflation conventional
Intervention Description
Conventional settings in a commercially available chest physiotherapy device
Intervention Type
Device
Intervention Name(s)
Mechanical insufflation/exsufflation modified
Intervention Description
Modified settings in a commercially available chest physiotherapy device
Primary Outcome Measure Information:
Title
Change in end-expiratory lung impedance from baseline
Description
Change of end-expiratory lung volume estimated by electrical impedance tomography from baseline to immediately after a session of mechanical insufflation/exsufflation.
Time Frame
3-5 Minutes
Secondary Outcome Measure Information:
Title
Change in ventilation distribution from baseline
Description
Differences in ventilation distribution assessed with electrical impedance tomography from baseline to immediately after a session of mechanical insufflation/exsufflation.
Time Frame
3-5 Minutes
Title
Duration of effect
Description
Duration of the postulated effect on lung volume assessed by electrical impedance tomography.
Time Frame
15-20 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Riedel, MD
Phone
+41316640065
Email
thomas.riedel@insel.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Carmen Casaulta, MD
Phone
+41316329551
Email
carmen.casaulta@insel.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Riedel, MD
Organizational Affiliation
Inselspital, Bern University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Inselspital
City
Bern
State/Province
BE
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Riedel, MD
Phone
+41 31 664 00 65
Email
thomas.riedel@insel.ch

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD sharing upon request
IPD Sharing Time Frame
Available from time of publication for up to two years
IPD Sharing Access Criteria
email: thomas.riedel@insel.ch
Citations:
PubMed Identifier
35488044
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.
Results Reference
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Mechanical Insufflator/Exsufflator Technique in Children With Neuromuscular Disease

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