Status:
TERMINATED
Evaluation of a Mechanical Device During Acute Respiratory Failure in Patients With Neuromuscular Disorders
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Duchenne Muscular Dystrophy
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
4+ years
Phase:
PHASE3
Brief Summary
The hypothesis is that a mechanical insufflation-exsufflation (MI-E) is associated with a decrease in the number of intubations and more rapid clinical improvement in children and adults with neuromus...
Detailed Description
Justification Respiratory muscle weakness reduces the efficacy of the cough reflex in patients with neuromuscular disorders and exposes them to the risk of acute respiratory failure. Mechanical insuff...
Eligibility Criteria
Inclusion
- Pediatric or adult patients with chronic neuromuscular disorders, such as spinal muscular atrophy, Duchenne muscular dystrophy, other congenital myopathy, or amyotrophic lateral sclerosis (ALS), hospitalized for acute respiratory failure, as defined by:
- Persistent bronchial encumbrance (\> 2 days) despite regular treatment in the homecare setting, associated with-Oxygen desaturation on room air, defined by a pulse oximetry (SaO2) \<95%) or
- In patients not receiving long-term NPPV: the need to institute NPPV-In patients receiving long-term NPPV: the need to increase the daily length of NPPV by at least 25%.
Exclusion
- Need for immediate intubation (alteration in consciousness, coma, hemodynamic disorders)
- Multiple organ failure (e.g., associated cardiac failure)
- In adults: respiratory rate \>30/min, pH \< 7.35, PaCO2 \> 50 mm Hg
- Facial deformity or anomaly which prevents the use of a mouthpiece or mask
- Patients who signed a refusal to be intubated regardless of the progression of their disease
- Patients on long-term oxygen therapy
- Tracheotomized patients
- Patients requiring the use of an intrapulmonary percussive ventilation device during hospitalization
- Acute neuromuscular disorder of known or unknown etiology
- Associated lung disease such as chronic obstructive pulmonary disease (COPD)
- Refusal of patient consent and/or parental consent in the case of a minor
- Uncooperative patients
- Patients \< 4 years old
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00839033
Start Date
June 1 2009
End Date
December 1 2011
Last Update
May 28 2015
Active Locations (1)
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1
Hospital Armand Trousseau, Pediatric Pulmonology Department and INSERM UMR S-893
Paris, France, 75012