NCT04081116

Mechanical Insufflation -Exsufflation in Children With NMD and Weak Cough

The Optimal Settings of MI-E in Children With NMD and Weak Cough

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 6 Months – 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Neuromuscular Diseases in Children

Interventions

Type	Name	Description
OTHER	Symmetric settings (high pressures/fast rate)	Describes settings on the MI-E device
OTHER	Asymmetric settings (Pi<Pe/Ti>Te)	Lower insufflation pressures at longer times
OTHER	Preinclusion settings	Settings in use at start of study

Timeline

• Start date: 2019-01-01
• Primary completion: 2021-02-28
• Completion: 2021-02-28
• First posted: 2019-09-09
• Last updated: 2023-01-20

Locations

4 sites across 1 country: Norway