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Clinical Trials/NCT05346263
NCT05346263
Recruiting
Not Applicable

Efficacy of Intermittent Abdominal Pressure Ventilation in Neuromuscular Patients: Multicentre, Randomised Controlled Trial

Fondazione Don Carlo Gnocchi Onlus1 site in 1 country78 target enrollmentMarch 1, 2022

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2022
End Date
March 1, 2025
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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)

Study Sites (1)

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