NCT03452618

Predictive Factors for the Diagnosis of Early Noninvasive Ventilation Equipment

Predictive Factors for the Diagnosis of Early Noninvasive Ventilation Equipment in Patients With Amyotrophic Lateral Sclerosis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To compensate for insufficiency of diagnostic tools, the present study propose to look for the predictive factors of an early fitting by noninvasive ventilation.

Detailed description

Amyotrophic lateral sclerosis (ALS) is the most common motor neuron disease. The diagnosis of this diaphragmatic dysfunction in the ALS subject is done all too often on the occasion of a hospitalization for acute respiratory insufficiency, which aggravates then the prognosis of the patients. The presence of these factors at diagnosis will allow more surveillance to detect early diaphragmatic insufficiency and establish a NIV (Non Invasive Ventilation), the only therapeutic measure definitely improving the quality of life and survival of patients. A clinical score will be established to determine the risk of early Non Invasive Ventilation (NIV) equipment.

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	diagnosis variables	The study compare the diagnostic variables in patients who received Non invasive ventilation equipment one year after diagnosis with the patient who don't need it. For the independent variables, the present study determine a threshold at the diagnosis for which an early fitting risk appears The diagnostic variable are : * Age of the patient * Sex * Presence of bulbar involvement or not * Time from onset of first symptoms to diagnosis of ALS * Score ALSFRS-R * Presence of another underlying respiratory pathology (COPD, asthma ...) * FVC measurement (Forced vital capacity) * PaCO2 measurement * Measure SNIP (Sniff nasal inspiratory pressure) * Measure of Pimax (Pressure inspiratory maximal) * Measurement of the nocturnal desaturation index (number of desaturation less than 90% per hour of sleep)

Timeline

• Start date: 2017-12-14
• Primary completion: 2021-12-14
• Completion: 2022-12-14
• First posted: 2018-03-02
• Last updated: 2021-09-01

Locations

1 site across 1 country: France