Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT02288299 |
Date of registration:
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05/11/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Long-Term Effect of LIAM on Respiratory Performance in NIV Patients Suffering From Neuromuscular Disease
LIAM |
Scientific title:
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Long-Term Effect of LIAM (Lung Insufflation Assist Maneuver) on Respiratory Performance in Non-invasive Ventilated Patients Suffering From Neuromuscular Disease |
Date of first enrolment:
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October 29, 2015 |
Target sample size:
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30 |
Recruitment status: |
Recruiting |
URL:
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https://clinicaltrials.gov/show/NCT02288299 |
Study type:
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Interventional |
Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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David Orlikowski, MD, PhD |
Address:
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Telephone:
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33147107776 |
Email:
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david.orlikowski@rpc.aphp.fr |
Affiliation:
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Name:
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David Orlikowski, MD, PhD |
Address:
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Telephone:
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+33(0)147107777 |
Email:
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david.orlikowski@rpc.aphp.fr |
Affiliation:
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Name:
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David Orlikowski, MD, PhD |
Address:
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Telephone:
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Email:
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Affiliation:
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Assistance Publique - Hôpitaux de Paris |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- o neuromuscular disease ( progressive muscular dystrophy, for example; Duchenne
muscular dystrophy, spinal muscular atrophy)
- age = 18 years
- indication to NIV (ongoing ventilation or new patients)
- vital capacity = 50% pred
- peak cough flow < 270 l/min
- "LIAM Responder" = increased insufflation capacity (= + 50%) and Peak Cough Flow
(PCF =+ 50%) with LIAM
Exclusion Criteria:
- o acute respiratory failure (respiratory acidosis)
- home treatment by instrumental cough assistance in the preceding 12 months
- ongoing medical treatment of the neuromuscular disease (for ex: corticosteroids
in Duchenne disease, enzyme therapy in Pompe disease)
- previous pneumothorax
- plan of legal protection
- pregnant or breastfeeding women
- failure to cooperate
- no affiliation to a social security scheme
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Neuromuscular Disease
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Intervention(s)
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Device: non invasive mechanical ventilation
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Primary Outcome(s)
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Change in the maximal assisted vital capacity (maximal insufflation capacity) between the begin of the treatment period and the 3-months follow up
[Time Frame: 15 minutes]
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Secondary Outcome(s)
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optoelectronic plethysmography
[Time Frame: 1 hour]
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peak flow
[Time Frame: 15 minutes]
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spontaneous vital capacity
[Time Frame: 15 minutes]
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Secondary ID(s)
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2014-A01005-42
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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