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Efficacy of Intermittent Abdominal Pressure Ventilation in Neuromuscular Patients

NCT ID: NCT05346263

Last Updated: 2022-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2025-03-01

Brief Summary

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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

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Conditions

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Neuromuscular Diseases

Keywords

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Neuromuscular Diseases; Intermittent Abdominal Pressure Ventilation; IAPV;

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

Intermittent Abdominal Pressure Ventilation

Intervention Type DEVICE

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

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

Group Type ACTIVE_COMPARATOR

Usual ventilation

Intervention Type DEVICE

NIV

Interventions

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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.

Intervention Type DEVICE

Usual ventilation

NIV

Intervention Type DEVICE

Other Intervention Names

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IAPV

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCS S. Maria Nascente - Fondazione Don Carlo Gnocchi

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Paolo Banfi, MD

Role: CONTACT

Phone: 00390240308812

Email: [email protected]

Valeria Volpi, PT

Role: CONTACT

Email: [email protected]

Facility Contacts

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Paolo Banfi, MD

Role: primary

Other Identifiers

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19/2021/CE_FdG/FC/SA

Identifier Type: -

Identifier Source: org_study_id