Efficacy of Intermittent Abdominal Pressure Ventilation in Neuromuscular Patients

Not Applicable

Recruiting

• Conditions: Neuromuscular Diseases
• Interventions: Device: Intermittent Abdominal Pressure Ventilation; Device: Usual ventilation

• Registration Number: NCT05346263
• Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-03
• Study Start: 2022-03-01
• Study First Submitted: 2022-04-13
• Study First Submitted QC: 2022-04-20
• Study First Posted: 2022-04-26
• Last Update Submitted: 2022-12-15
• Last Update Posted: 2022-12-19
• Primary Completion: 2023-10-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intermittent Abdominal Pressure Ventilation	Intermittent Abdominal Pressure Ventilation	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)
Usual ventilation	Usual ventilation	Patients in control group continue with usual ventilation (NIV through mouthpiece or nasal-pillow)

Primary Outcome Measures

Name	Time	Method
Blood Gas Analysis	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 Outcome Measures

Name	Time	Method
Therapy adherence	12 months	Adherence to IAPV tested with Beliefs about Ventilation Questionnaire (BVQ). BVQ is a qualitative questionnaire: it consist of 25 items, where higher scores mean a better outcome.
Patients satisfaction to IAPV	12 months	Satisfaction to IAPV tested with Visual Analog Scale (VAS), with a score that ranges between 0 and 10, where a higher score means a worse outcome.
Caregivers satisfaction to IAPV	12 months	Satisfaction to IAPV tested with Visual Analog Scale (VAS), with a score that ranges between 0 and 10, where a higher score means a worse outcome.
Amelioration of Quality of life	12 months	Improvement of quality of life tested with World Health Organization Quality of Life-Brief (WHOQOL-Brief), with a score ranging from 0 to 100 for each of the four domain and where a higher score means a better outcome

Trial Locations

Locations (1)

IRCCS S. Maria Nascente - Fondazione Don Carlo Gnocchi; 🇮🇹 Milan, Italy