- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00839033
Evaluation of a Mechanical Device During Acute Respiratory Failure in Patients With Neuromuscular Disorders (Nemucough)
Evaluation of a Mechanical Insufflation-exsufflation Device During Acute Respiratory Failure in Patients With Neuromuscular Disorders: a Prospective, Randomized, Controlled, Multicenter Study
Study Overview
Status
Intervention / Treatment
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 insufflation-exsufflation devices assist cough and have been shown to be efficient in increasing the cough expiratory flow in children and adults with neuromuscular disease and decreasing the risk of intubation in a limited population of hospitalized adults with acute respiratory failure.
Primary objective The goal is to record the efficacy of mechanical insufflation-exsufflation (MI-E) during acute respiratory failure in patients with neuromuscular disorders.The primary objective is the reduction of the number of patients requiring invasive ventilatory support (endotracheal intubation or tracheotomy) in the group treated with MI-E (MI-E group) compared to the group treated with traditional chest physiotherapy without MI-E (Control group).
Secondary objectives
In the MI-E group, compared to the Control group:
- Decrease in the length of hospitalization in the intensive care unit (ICU)
- Decrease in the total length of hospitalization
- Decrease in the incidence of bronchoscopy-assisted aspiration
- Decrease in the duration of oxygen therapy
- Decrease in the daily length of noninvasive positive pressure ventilation (NPPV)
- Improvement in blood gases on room air during hospitalization
- Improvement of the peak cough flow (PCF)
- Improvement of the vital capacity (VC), maximal inspiratory (PImax) and expiratory (PEmax) pressures, sniff nasal inspiratory pressure (SNIP), peak expiratory flow (PEF) and dyspnea during hospitalization.
- Decrease in the number of secondary tracheotomies (for weaning of ventilatory support)
Type of study Prospective, randomized, controlled, multicenter study
Number of subjects The calculation of the number of subjects is based on two retrospective studies. In the study by VIANELLO, which included 11 adults hospitalized in the ICU for respiratory failure, the number of therapeutic failures, defined as the need for a "mini" tracheotomy or intubation, was significantly less in the group using MI-E than in a group of 16 historical control patients [2 failures in the MI-E group (18%) versus 10 failures in the control group (63%), p<0.05] (1). Another study reported 19 successes (80%) versus 5 failures on MI-E (2).
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Paris, France, 75012
- Hospital Armand Trousseau, Pediatric Pulmonology Department and INSERM UMR S-893
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
patients treated with standard treatment and a mechanical insufflation-exsufflation
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Patients will receive MI-E treatment with the following settings: insufflation pressure of at least +30 cm H2O and an exsufflation pressure ≥ -30 cm H2O.
There will be at least 6 hyperinflation/exsufflation sequences per session of chest physiotherapy.
There will be at least two daily sessions done routinely by the respiratory therapist at 8 hour intervals.
Other Names:
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Active Comparator: 2
Patients with standard treatment and standard respiratory physiotherapy
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Traditional chest physiotherapy without mechanical insufflation-exsufflation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction of the number of patients requiring invasive ventilatory support in the group treated with MI-E (MI-E group) compared to the group treated with traditional chest physiotherapy without MI-E (Control group).
Time Frame: During the treatment phase
|
During the treatment phase
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Decrease in the length of hospitalization in the intensive care unit (ICU) (if necessary)
Time Frame: During the treatment phase
|
During the treatment phase
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Decrease in the total length of hospitalization
Time Frame: During the treatment phase
|
During the treatment phase
|
Decrease in the incidence of bronchoscopy-assisted aspiration
Time Frame: During the treatment phase
|
During the treatment phase
|
Decrease in the duration of oxygen therapy
Time Frame: During the treatment phase
|
During the treatment phase
|
Decrease in the daily length of noninvasive positive pressure ventilation (NPPV)
Time Frame: During the treatment phase
|
During the treatment phase
|
Improvement in blood gases on room air during hospitalization and improvement of the peak cough flow (PCF)
Time Frame: During the treatment phase
|
During the treatment phase
|
Improvement of the vital capacity (VC), maximal inspiratory (PImax) and expiratory (PEmax) pressures, sniff nasal inspiratory pressure (SNIP), peak expiratory flow (PEF) and dyspnea during hospitalization
Time Frame: During the treatment phase
|
During the treatment phase
|
Decrease in the number of secondary tracheotomies (for weaning of ventilatory support)
Time Frame: During the treatment phase
|
During the treatment phase
|
Collaborators and Investigators
Investigators
- Principal Investigator: Brigitte FAUROUX, MD PhD, Assistance Publique - Hôpitaux de Paris
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Metabolic Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Genetic Diseases, Inborn
- Genetic Diseases, X-Linked
- Musculoskeletal Diseases
- Muscular Diseases
- Neurodegenerative Diseases
- Spinal Cord Diseases
- TDP-43 Proteinopathies
- Proteostasis Deficiencies
- Muscular Disorders, Atrophic
- Respiratory Insufficiency
- Motor Neuron Disease
- Amyotrophic Lateral Sclerosis
- Muscular Dystrophies
- Muscular Dystrophy, Duchenne
- Neuromuscular Diseases
Other Study ID Numbers
- P080406
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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