Tolerability, Safety and Efficacy of Sigh Breaths During NIMV in Motor Neuron Disease
NCT ID: NCT04240925
Last Updated: 2022-03-16
Study Results
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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UNKNOWN
NA
44 participants
INTERVENTIONAL
2018-05-25
2022-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Standard NIMV protocol with sigh breaths
NIMV with sigh breaths
Sigh breaths: Maximal Inspiratory pressure (IPAPmax) increased of at least 25% ( ≥ 125%) with a frequency of at least 1/200 breaths. The sigh breaths will be delivered as part of the standard NIMV protocol
Standard NIMV protocol without sigh breaths
Standard NIMV
Will be treated by standard NIMV with no sigh
Interventions
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NIMV with sigh breaths
Sigh breaths: Maximal Inspiratory pressure (IPAPmax) increased of at least 25% ( ≥ 125%) with a frequency of at least 1/200 breaths. The sigh breaths will be delivered as part of the standard NIMV protocol
Standard NIMV
Will be treated by standard NIMV with no sigh
Eligibility Criteria
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Inclusion Criteria
* MND diagnosis according to El-Escorial criteria
* Non-invasive ventilation indications in accordance with the international guidelines
Exclusion Criteria
* Presence of dementia
* History of arrhythmia, heart failure or pneumothorax
ALL
No
Sponsors
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Ospedale San Raffaele
OTHER
Responsible Party
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Nilo Riva
Principal Investigator
Principal Investigators
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nilo riva, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Ospedale San Raffaele
Locations
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Ospedale San Raffaele
Milan, , Italy
Countries
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Other Identifiers
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SIGH_01
Identifier Type: -
Identifier Source: org_study_id
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