Mechanical Insufflation -Exsufflation in Children With NMD and Weak Cough

Neuromuscular Diseases in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04081116
• Other study ID #: 18/12375
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: February 28, 2021

Study information

• Verified date: January 2023
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neuromuscular Diseases
• Neuromuscular Diseases in Children

Intervention

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

Locations

Country	Name	City	State
Norway	Helse bergen HF	Bergen
Norway	Oslo university hospital	Oslo
Norway	Stavanger university hospital	Stavanger
Norway	St. Olav Trondheim university hospital	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PCF in the MI-E circuit	Recording of maximal value produced by the MI-E device during Cough	30 minutes.
Primary	Patient reported comfort	Comfort rated on a Visual Analog Scale (VAS) (0-100) where 100 is very uncomfortable and 0 is very comfortable.	Total time use 30 min
Secondary	Carbon dioxide	Transcutaneous trend measurement of CO2 during data collection	maximal time use is 30 min
Secondary	Oxygen	Transcutaneous trend measurement of peripheral O2 during data collection	maximal time use is 30 min
Secondary	Hart rate	Transcutaneous trend measurement of hart rate during data collection	Total max 30 minutes (During three MI-E trials)
Secondary	Patient reported efficacy	Efficacy rated on a Visual Analog Scale (0-100) where 100 is not efficient at all and 0 is very efficient.	The VAS is recorded after each of the three trials. Total time use 30 min