Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT00839033
Eligibility Criteria:
Inclusion Criteria:
Pediatric or adult patients with chronic neuromuscular disorders, such as spinal muscular atrophy, Duchenne muscular dystrophy, other congenital myopathy, or amyotrophic lateral sclerosis (ALS), hospitalized for acute respiratory failure, as defined by:
* Persistent bronchial encumbrance (\> 2 days) despite regular treatment in the homecare setting, associated with-Oxygen desaturation on room air, defined by a pulse oximetry (SaO2) \<95%) or
* In patients not receiving long-term NPPV: the need to institute NPPV-In patients receiving long-term NPPV: the need to increase the daily length of NPPV by at least 25%.
Exclusion Criteria:
* Need for immediate intubation (alteration in consciousness, coma, hemodynamic disorders)
* Multiple organ failure (e.g., associated cardiac failure)
* In adults: respiratory rate \>30/min, pH \< 7.35, PaCO2 \> 50 mm Hg
* Facial deformity or anomaly which prevents the use of a mouthpiece or mask
* Patients who signed a refusal to be intubated regardless of the progression of their disease
* Patients on long-term oxygen therapy
* Tracheotomized patients
* Patients requiring the use of an intrapulmonary percussive ventilation device during hospitalization
* Acute neuromuscular disorder of known or unknown etiology
* Associated lung disease such as chronic obstructive pulmonary disease (COPD)
* Refusal of patient consent and/or parental consent in the case of a minor
* Uncooperative patients
* Patients \< 4 years old
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Study:
NCT00839033
Study Brief:
Protocol Section:
NCT00839033