Efficacy of Intermittent Abdominal Pressure Ventilation in Neuromuscular Patients

Neuromuscular Diseases Clinical Trial

— IAPV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05346263
• Other study ID #: 19/2021/CE_FdG/FC/SA
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: March 1, 2025

Study information

• Verified date: March 2022
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: Paolo Banfi, MD
• Phone: 00390240308812
• Email: pabanfi[@]dongnocchi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: March 1, 2025
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Neuromuscular Diseases

Intervention

Device:
• Intermittent Abdominal Pressure Ventilation
Patients of experimental group will use IAPV in daytime ventilation. Intermittent abdominal pressure ventilation (IAPV) is a portable ventilator with an internal battery and PneumoBelt corset as an interface.
• Usual ventilation
NIV

Locations

Country	Name	City	State
Italy	IRCCS S. Maria Nascente - Fondazione Don Carlo Gnocchi	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Gas Analysis	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	12 months
Secondary	Therapy adherence	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.	12 months
Secondary	Patients satisfaction to IAPV	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.	12 months
Secondary	Caregivers satisfaction to IAPV	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.	12 months
Secondary	Amelioration of Quality of life	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	12 months