Efficacy of Intermittent Abdominal Pressure Ventilation in Neuromuscular Patients: Multicentre, Randomised Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neuromuscular Diseases
- Sponsor
- Fondazione Don Carlo Gnocchi Onlus
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Blood Gas Analysis
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
Non-Invasive Ventilation (NIV) is an established treatment to manage respiratory muscles dysfunction in neuromuscular disease, preventing the progression of respiratory failure to intubation and/or a tracheotomy. NIV is commonly needed at first during the night, but when the disease worsens, it is required during the day. It is provided via nasal or oronasal masks, causing discomfort and/or aesthetic issues that result in poor compliance.
Intermittent Abdominal Pressure Ventilation (IAPV) is a valid, though unconventional, alternative to daytime NIV: it consists of a portable ventilator with an internal battery and a corset as interface. The IAPV corset is lightweight, comfortable and, thanks to velcro fasteners, easier and better fitting than a face mask. Cyclical inflation of a rubber bladder inside the corset moves the diaphragm upwards like a pneumobelt causing air to enter in the lungs via the upper airways as gravity draws the diaphragm back to its resting position.
IAPV is indicated in neuromuscular disease and has already been tested in few preliminary studies and case reports. This study wants to verify the hypothesis of its application in population of neuromuscular patients.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of Neuromuscular Disease (Amyotrophic Lateral Sclerosis, Duchenne Muscular Dystrophy, Spinal Muscular Atrophy, Pompe Disease)
- •Non Invasive Ventilation \> 16 hours/day
- •Informed consent signed
Exclusion Criteria
- •Diagnosis of kyphoscoliosis
Outcomes
Primary Outcomes
Blood Gas Analysis
Time Frame: 12 months
Changes of respiratory parameters in terms of normalization of oxyemia (Arterial Pressure of oxygen 80-100 mmHg) and normalization of capnia (Arterial Pressure of carbon dioxide 35-45 mmHg), assessed by blood gas analysis
Secondary Outcomes
- Therapy adherence(12 months)
- Patients satisfaction to IAPV(12 months)
- Caregivers satisfaction to IAPV(12 months)
- Amelioration of Quality of life(12 months)