NCT04081116|Completed
Mechanical Insufflation -Exsufflation in Children With NMD and Weak Cough
The Optimal Settings of MI-E in Children With NMD and Weak Cough
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The Optimal Settings of MI-E in Children With NMD and Weak Cough
Sponsor study identifier
interventional
77
1 country
4
Study Start
January 1, 2019
Actual (reported)Primary Completion
February 28, 2021
Actual (reported)Study Completion
February 28, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 28, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2019
Actual (reported)February 4, 2019
Actual (reported)September 9, 2019
Actual (reported)February 28, 2021
Actual (reported)February 28, 2021
Actual (reported)PCF in the MI-E circuit
Recording of maximal value produced by the MI-E device during Cough
30 minutes.
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
Carbon dioxide
maximal time use is 30 min
Oxygen
maximal time use is 30 min
Hart rate
Total max 30 minutes (During three MI-E trials)
Patient reported efficacy
The VAS is recorded after each of the three trials. Total time use 30 min
Symmetric settings is one of 3 different settings that will be tested on the same day but in randomized order.
Asymmetric settings is one of 3 different settings that will be tested on the same day but in randomized order.
Describes settings on the MI-E device
Lower insufflation pressures at longer times
Helse bergen HF
Bergen, Norway
Oslo university hospital
Oslo, Norway
Stavanger university hospital
Stavanger, Norway
St. Olav Trondheim university hospital
Trondheim, Norway
Morrow B, Argent A, Zampoli M, Human A, Corten L, Toussaint M. Cough augmentation techniques for people with chronic neuromuscular disorders. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013170. doi: 10.1002/14651858.CD013170.pub2.
77 participants (actual enrollment reported by the registry).
First Submitted
February 4, 2019
First Posted
September 9, 2019
Settings in use is one of 3 different settings that will be tested on the same day but in randomized order
Settings in use at start of study
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Study Start
January 1, 2019
Actual (reported)Primary Completion
February 28, 2021
Actual (reported)Study Completion
February 28, 2021
Actual (reported)Last Updated
January 20, 2023
Record last verified: 2023-01
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Source: ClinicalTrials.gov.
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