Predictive Factors for the Diagnosis of Early Noninvasive Ventilation Equipment

University Hospital, Toulouse100 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

100

Conditions

Amyotrophic Lateral Sclerosis

Interventions

diagnosis variablesDIAGNOSTIC_TEST

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)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * diagnosis of amyotrophic lateral sclerosis just performed, * Patient who do not have the criteria for fitting by NIV and who have a Vital capacity ≥ 70% of theoretical values Exclusion Criteria: * Patient under court bail/ guardianship * Lack of consent for participation in the study * Presence of criteria for setting up the NIV for diagnosis according to the HAS (HealthCare Analytics Summit) 2006 recommendations * Vital capacity \<70% of the theoretical values * Patient under Continuous Positive Pressure (CPP) or NIV for a respiratory pathology other

Locations (1)

University Hospital Toulouse

Toulouse, France

RECRUITING

Outcomes

Primary Outcomes

Early Surgical Clinical Score

An Early Surgical Clinical Score will be established taking into account the independent variables correlated to diagnosis at early fitting. Clinical Variables : * Presence of bulbar involvement or not * Time from onset of first symptoms to diagnosis * Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R) score : The Amyotrophic Lateral Sclerosis Functional Ra ting Scale (ALSFRS) is an instrument for evaluating the functional status of patients with Amyotrophic Lateral Sclerosis. It can be used to monitor functional change in a patient over time. * Presence of another underlying respiratory disease Functional Variables : * Time from onset of first symptoms to diagnosis of ALS * Presence of another underlying respiratory pathology * Forced Vital Capacity (FVC) measurement * PaCO2 measurement * Measure Sniff Nasal Inspiratory Pressure (SNIP) * Measurement of diaphragmatic activity on ultrasound * Parameters of the Polysomnography (PSG)

Time frame: One year after diagnostic

Secondary Outcomes

Sensitivity, specificity, negative and positive predictive values

Sensitivity, specificity, negative and positive predictive values of the diaphragmatic ultrasound (fraction of shortening and diaphragmatic stroke) compared to the SNIP test and for the values of PSG (Polysomnography) compared to SNIP test

Time frame: One year after the diagnostic

Percentage of decrease

% decrease in shortening fraction and diaphragmatic stroke between two quarterly reevaluations correlated with early fitting and % decrease in FVC, SNIP test et Pimax

Time frame: One year after the diagnostic

Slope of FVC decline

Slope of FVC decline before and after NIV implementation and slope of decline of shortening fraction and diaphragmatic stroke before and after NIV

Time frame: One year after the diagnostic

Central Contacts

Marion Dupuis, MD

CONTACT

5 67 77 16 91 dupuis.m@chu-toulouse.fr

Isabelle Olivier, PhD

CONTACT

5 61 77 70 51 olivier.i@chu-toulouse.fr

Data from ClinicalTrials.gov

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