Mechanical Insufflation -Exsufflation in Children With NMD and Weak Cough
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MI-E testing symmetric settings Symmetric settings is one of 3 different settings that will be tested on the same day but in randomized order. |
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
|
| Experimental: MI-E testing assymetric settings Asymmetric settings is one of 3 different settings that will be tested on the same day but in randomized order. |
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
|
| Sham Comparator: Settings in use Settings in use is one of 3 different settings that will be tested on the same day but in randomized order |
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
|
Outcome Measures
Primary Outcome Measures
- PCF in the MI-E circuit [30 minutes.]
Recording of maximal value produced by the MI-E device during Cough
- Patient reported comfort [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 Outcome Measures
- Carbon dioxide [maximal time use is 30 min]
Transcutaneous trend measurement of CO2 during data collection
- Oxygen [maximal time use is 30 min]
Transcutaneous trend measurement of peripheral O2 during data collection
- Hart rate [Total max 30 minutes (During three MI-E trials)]
Transcutaneous trend measurement of hart rate during data collection
- Patient reported efficacy [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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Helse bergen HF | Bergen | Norway | ||
| 2 | Oslo university hospital | Oslo | Norway | ||
| 3 | Stavanger university hospital | Stavanger | Norway | ||
| 4 | St. Olav Trondheim university hospital | Trondheim | Norway |
Sponsors and Collaborators
- Oslo University Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 18/12375