Predictive Factors for the Diagnosis of Early Noninvasive Ventilation Equipment

Amyotrophic Lateral Sclerosis Clinical Trial

— PREDAPP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03452618
• Other study ID #: RC31/17/0201
• Secondary ID: 2017-A02202-51
• Status: Recruiting
• Phase: N/A
• Start date: December 14, 2017
• Est. completion date: December 14, 2022

Study information

• Verified date: August 2021
• Source: University Hospital, Toulouse
• Contact: Marion Dupuis, MD
• Phone: 5 67 77 16 91
• Email: dupuis.m[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 14, 2022
• Est. primary completion date: December 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

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)

Locations

Country	Name	City	State
France	University Hospital Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	One year after diagnostic
Secondary	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	One year after the diagnostic
Secondary	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	One year after the diagnostic
Secondary	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	One year after the diagnostic
Secondary	Quality of life score	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.	One year after the diagnostic