Mechanical Insufflation -Exsufflation in Children With NMD and Weak Cough

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

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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)