Trials Sponsors Conditions Drugs Pricing

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 conventionalDevice: 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.

Interventions

Mechanical insufflation/exsufflation conventionalDevice

Conventional settings in a commercially available chest physiotherapy device

Conventional settings first, modified settings secondModified settings first, conventional settings second

Mechanical insufflation/exsufflation modifiedDevice

Modified settings in a commercially available chest physiotherapy device

Eligibility Criteria

Age5 Years - 16 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Confirmed diagnosis of a NMD
Functional status: non-ambulatory

Sponsors & Collaborators

Insel Gruppe AG, University Hospital Bern
Otherlead

Study Sites (1)

Inselspital

Bern, Canton of Bern, 3010, Switzerland

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: 35488044BACKGROUND

Study Officials

Thomas Riedel, MD
Inselspital, Bern University Hospital
STUDY DIRECTOR

Enrollment

7 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

July 6, 2022

First Posted

July 12, 2022

Study Start

February 1, 2023

Actual (reported)

Mechanical Insufflator/Exsufflator Technique in Children With Neuromuscular Disease

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Conventional settings first, modified settings second

Modified settings first, conventional settings second

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Conventional settings first, modified settings second

Modified settings first, conventional settings second

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations