Mechanical Insufflation -Exsufflation in Children With NMD and Weak Cough

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2021-02-28

Brief Summary

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Neuromuscular diseases (NMD) in children are severe, possibly life-threatening orphan conditions. The children are vulnerable and often subject to rapid deterioration of pulmonary function due to impaired ability to clear airway secretions. The use of mechanical cough augmentation with insufflation-exsufflation (MIE) is a strategy to treat and prevent. Possible major benefits are described, but optimal settings for best efficacy and comfort in children are not established. The project aim to improve the quality of the treatment with MIE in children with NMD and weak cough. On the basis of a bench study a clinical trial aims to examine the most effective MIE settings when used in stable state and when respiratory tract infections are present.

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Detailed Description

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On the basis of a prevalence study and a bench study different settings will be studied in children with NMD and weak cough to examine if settings derived from the lung model, are optimal to increase the peak cough flow (PCF) and comfort measured by visual analogue scale (VAS) in children with NMD and weak cough.

Conditions

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Neuromuscular Diseases in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Three different settings are tested on the same patients but in randomized order.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Participant, care provider, investigator and outcomes assessor are blinded from the order of the settings tested. Only a technician change settings and know the order.

Study Groups

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MI-E testing symmetric settings

Symmetric settings is one of 3 different settings that will be tested on the same day but in randomized order.

Group Type EXPERIMENTAL

Symmetric settings (high pressures/fast rate)

Intervention Type OTHER

Describes settings on the MI-E device

Asymmetric settings (Pi<Pe/Ti>Te)

Intervention Type OTHER

Lower insufflation pressures at longer times

Preinclusion settings

Intervention Type OTHER

Settings in use at start of study

MI-E testing assymetric settings

Asymmetric settings is one of 3 different settings that will be tested on the same day but in randomized order.

Group Type EXPERIMENTAL

Symmetric settings (high pressures/fast rate)

Intervention Type OTHER

Describes settings on the MI-E device

Asymmetric settings (Pi<Pe/Ti>Te)

Intervention Type OTHER

Lower insufflation pressures at longer times

Preinclusion settings

Intervention Type OTHER

Settings in use at start of study

Settings in use

Settings in use is one of 3 different settings that will be tested on the same day but in randomized order

Group Type SHAM_COMPARATOR

Symmetric settings (high pressures/fast rate)

Intervention Type OTHER

Describes settings on the MI-E device

Asymmetric settings (Pi<Pe/Ti>Te)

Intervention Type OTHER

Lower insufflation pressures at longer times

Preinclusion settings

Intervention Type OTHER

Settings in use at start of study

Interventions

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Symmetric settings (high pressures/fast rate)

Describes settings on the MI-E device

Intervention Type OTHER

Asymmetric settings (Pi<Pe/Ti>Te)

Lower insufflation pressures at longer times

Intervention Type OTHER

Preinclusion settings

Settings in use at start of study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosed neuromuscular disease \< 18 years
* Established use (\> 3mnd) of MI-E.
* Reduced PCF

* PCF \< 270 l/min (when \> 12 years)
* \< 5th percentiles for PCF 16 (when 4 - 12 years)
* Clinical indication (difficulty to clear secretions, audible weak cough, history of pneumonia or frequent or prolonged respiratory tract infections).