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Mechanical Insufflation -Exsufflation in Children With NMD and Weak Cough

University of Oslo (UIO) logo

University of Oslo (UIO)

Status

Completed

Conditions

Neuromuscular Diseases in Children

Treatments

Other: Preinclusion settings
Other: Asymmetric settings (Pi<Pe/Ti>Te)
Other: Symmetric settings (high pressures/fast rate)

Study type

Interventional

Funder types

Other

Identifiers

NCT04081116
18/12375

Details and patient eligibility

About

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.

Full description

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.

Enrollment

77 patients

Sex

All

Ages

6 months to 18 years old

Volunteers

No Healthy Volunteers

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).

Exclusion criteria

  • age < 6 mnd
  • obstructive lung disease (hyperinflation or emphysema on x-ray.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Quadruple Blind

77 participants in 3 patient groups

MI-E testing symmetric settings
Experimental group
Description:
Symmetric settings is one of 3 different settings that will be tested on the same day but in randomized order.
Treatment:
Other: Preinclusion settings
Other: Asymmetric settings (Pi<Pe/Ti>Te)
Other: Symmetric settings (high pressures/fast rate)
MI-E testing assymetric settings
Experimental group
Description:
Asymmetric settings is one of 3 different settings that will be tested on the same day but in randomized order.
Treatment:
Other: Preinclusion settings
Other: Asymmetric settings (Pi<Pe/Ti>Te)
Other: Symmetric settings (high pressures/fast rate)
Settings in use
Sham Comparator group
Description:
Settings in use is one of 3 different settings that will be tested on the same day but in randomized order
Treatment:
Other: Preinclusion settings
Other: Asymmetric settings (Pi<Pe/Ti>Te)
Other: Symmetric settings (high pressures/fast rate)

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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