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Mechanical Cough Augmentation in Children With NMD

Sponsor
Oslo University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03831568
Collaborator
University Hospital of North Norway (Other), St. Olavs Hospital (Other), Haukeland University Hospital (Other), Helse Stavanger HF (Other), Sorlandet Hospital HF (Other)
72
Enrollment
1
Location
13
Actual Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study investigates the prevalence and use of mechanical insufflation - exsufflation (MI-E) in children with Neuromuscular disorders (NMD) in Norway. The NMD related prevalence of MIE use in Norway will be described and possible regional differences regarding use will be assessed.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Neuromuscular diseases (NMD) in children are severe, possibly life-threatening orphan conditions. Respiratory tract infections and lung complications are the main causes of increased morbidity and mortality.

    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 main objective is to determine the prevalence and use of MIE among children with NMD in Norway. All children with NMD < 18 years which has received a machine for MI-E will be invited to participate in the study.

    The participants will be asked to complete two questionnaires. In addition will information from the data card in the MI-E machines give information about use. The information will be linked to the National register for Long term mechanical ventilation.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    72 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Prevalence and Use of Mechanical Cough Augmentation in Children With Neuromuscular Disorders in Norway
    Actual Study Start Date :
    Jan 1, 2018
    Actual Primary Completion Date :
    Jan 31, 2019
    Actual Study Completion Date :
    Jan 31, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    Children with given device for mechanical cough

    Outcome Measures

    Primary Outcome Measures

    1. Residency [At one point (1 day)]

      Name of county

    2. Indication for use [At one point (1 day)]

      Prevention or treatment purposes from questionnaire

    3. Diagnosis [01.01.2018]

      International Classification of Diseases - 10 diagnosis

    Secondary Outcome Measures

    1. Health related quality of life [One time at completion of questionaire]

      The DISABKIDS Chronic Generic Module (DCGM-37) is a questionnaire measuring general health-related quality of life (HRQoL) and the level of distress caused by a chronic disease at 3 domains (mental, social and physical) in 6 dimensions: Independence, Emotion, Social inclusion, Social exclusion, Limitation and Treatment. Each item is scored on a five-point Likert scale which indicates behavior or feelings as 1 = never, 2 = seldom, 3 = quite often, 4 = very often and 5 = always. There is one form to be filled in by children 8 to 18 years of age, and one form by their parents. The sum of scores within each dimension makes up the raw score, which is transformed linearly into a score ranging from 0 to 100. The scores are added and further transformed into a total HRQOL score with a range 0 to 100 with higher scores indicating higher HRQOL.

    2. Settings in use [One time at completion of questionaire]

      Recorded from data card in MIE machine

    3. Opinion on treatment [One time at completion of questionaire]

      A purpose made questionnaire including questions with predefined categorical data in no order, and 2 questions using a Visual Analog Scale 0-10 to score perceived benefit of the treatment where 0 indicates not important at all and 10 indicates very important.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria: ,

    • Received a MI-E device

    • Neuromuscular disease

    • < 18 years

    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Oslo university hospital Oslo Norway

    Sponsors and Collaborators

    • Oslo University Hospital
    • University Hospital of North Norway
    • St. Olavs Hospital
    • Haukeland University Hospital
    • Helse Stavanger HF
    • Sorlandet Hospital HF

    Investigators

    • Principal Investigator: Vegard Hovland, PhD, MD

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Brit Hov, Physiotherapist, MSc, Oslo University Hospital
    ClinicalTrials.gov Identifier:
    NCT03831568
    Other Study ID Numbers:
    • MIE 2016_14321
    • 17/9232
    • Hov_2017
    First Posted:
    Feb 6, 2019
    Last Update Posted:
    Sep 6, 2019
    Last Verified:
    Sep 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Brit Hov, Physiotherapist, MSc, Oslo University Hospital
    Airway management
    Cough
    Neuromuscular diseases
    Pediatrics
    Mechanical insufflation-exsufflation
    Additional relevant MeSH terms:
    Cough
    Neuromuscular Diseases

    Study Results

    No Results Posted as of Sep 6, 2019