Efficacy of Intermittent Abdominal Pressure Ventilation in Neuromuscular Patients (IAPV)

Don Carlo Gnocchi Onlus Foundation

Status

Enrolling

Conditions

Neuromuscular Diseases

Treatments

Device: Usual ventilation

Device: Intermittent Abdominal Pressure Ventilation

Study type

Interventional

Funder types

Other

Identifiers

NCT05346263

19/2021/CE_FdG/FC/SA

Details and patient eligibility

About

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.

Enrollment

78 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

78 participants in 2 patient groups

Intermittent Abdominal Pressure Ventilation

Experimental group

Description:

Patients in experimental group will be adapted to Intermittent Abdominal Pressure Ventilation (IAPV). Abdominal ventilation replaces part of usual ventilation (non invasive ventilation with mouthpiece or nasal-pillow)

Treatment:

Device: Intermittent Abdominal Pressure Ventilation

Usual ventilation

Active Comparator group

Description:

Patients in control group continue with usual ventilation (NIV through mouthpiece or nasal-pillow)

Treatment:

Device: Usual ventilation