Predictive Factors for the Diagnosis of Early Noninvasive Ventilation Equipment

Not Applicable

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Diagnostic Test: diagnosis variables

• Registration Number: NCT03452618
• Lead Sponsor: University Hospital, Toulouse

Brief 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.

Study Timeline

• Study Start: 2017-12-14
• Study First Submitted: 2018-02-26
• Study First Submitted QC: 2018-02-26
• Study First Posted: 2018-03-02
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-26
• Last Update Posted: 2021-09-01
• Primary Completion: 2021-12-14
• Study Completion: 2022-12-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patients with a NIV equipment	diagnosis variables	Determination of diagnosis variables in a group of patient who benefit of the Non Invasive ventilation equipment one year after the diagnostic
patients without a NIV equipment	diagnosis variables	Determination of diagnosis variables in a group of patient who not benefit of the Non Invasive ventilation equipment one year after the diagnostic

Primary Outcome Measures

Name	Time	Method
Early Surgical Clinical Score	One year after diagnostic	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)

Secondary Outcome Measures

Name	Time	Method
Sensitivity, specificity, negative and positive predictive values	One year after the diagnostic	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
Percentage of decrease	One year after the diagnostic	% decrease in shortening fraction and diaphragmatic stroke between two quarterly reevaluations correlated with early fitting and % decrease in FVC, SNIP test et Pimax
Slope of FVC decline	One year after the diagnostic	Slope of FVC decline before and after NIV implementation and slope of decline of shortening fraction and diaphragmatic stroke before and after NIV
Quality of life score	One year after the diagnostic	Quality of life score by the Severe Respiratory Insufficiency (SRI) questionnaire :before and after implementation of the NIV The Severe Respiratory Insufficiency (SRI) Questionnaire: a specific measure of health-related quality of life in patients receiving home mechanical ventilation.

Trial Locations

Locations (1)

University Hospital Toulouse; 🇫🇷 Toulouse, France