Tolerability Safety and Efficacy of Sigh Breaths During NIMV in Motor Neuron Disease

  • STATUS
    Recruiting
  • participants needed
    44
  • sponsor
    Ospedale San Raffaele
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Updated on 16 February 2024
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mechanical ventilation
non-invasive ventilation
motor neuron disease
noninvasive ventilation

Summary

Non-invasive mechanical ventilation (NIMV) is the recommended standard of care as initial therapy for patients with motor neuron disease (MND) with deterioration of the respiratory function.

SIGH_01 study is aimed at investigating the tolerability, safety profile and efficacy of sigh breaths during non-invasive mechanical ventilation in patients with MND in comparison to the standard ventilation support protocol.

Details
Condition Myelopathy, Respiratory Failure, Respiratory Failure, Amyotrophic Lateral Sclerosis, Motor Neuron Disease
Age 100years or below
Treatment NIMV with sigh breaths, Standard NIMV
Clinical Study IdentifierNCT04240925
SponsorOspedale San Raffaele
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Willing and able to give informed consent
MND diagnosis according to El-Escorial criteria
Non-invasive ventilation indications in accordance with the international guidelines

Exclusion Criteria

Inability to adhere to study visit schedule or lack of reliable caretaker
Presence of dementia
History of arrhythmia, heart failure or pneumothorax
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