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Completed

NCT Number: NCT04081116

Mechanical Insufflation -Exsufflation in Children With NMD and Weak Cough

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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Key information

Conditions

Neuromuscular Diseases in Children

Age range

6 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helse bergen HF, Bergen, Norway

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Symmetric settings (high pressures/fast rate)

Other

Describes settings on the MI-E device

Asymmetric settings (Pi<Pe/Ti>Te)

Other

Lower insufflation pressures at longer times

Preinclusion settings

Other

Settings in use at start of study

Primary outcomes

  1. PCF in the MI-E circuit

    Time frame: 30 minutes.

    Recording of maximal value produced by the MI-E device during Cough

  2. Patient reported comfort

    Time frame: Total time use 30 min

    Comfort rated on a Visual Analog Scale (VAS) (0-100) where 100 is very uncomfortable and 0 is very comfortable.

Secondary outcomes

  1. Carbon dioxide

    Time frame: maximal time use is 30 min

    Transcutaneous trend measurement of CO2 during data collection

  2. Oxygen

    Time frame: maximal time use is 30 min

    Transcutaneous trend measurement of peripheral O2 during data collection

  3. Hart rate

    Time frame: Total max 30 minutes (During three MI-E trials)

    Transcutaneous trend measurement of hart rate during data collection

  4. Patient reported efficacy

    Time frame: The VAS is recorded after each of the three trials. Total time use 30 min

    Efficacy rated on a Visual Analog Scale (0-100) where 100 is not efficient at all and 0 is very efficient.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 9, 2019
Registry last updated
Jan 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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