Study Purpose:
To compensate for insufficiency of diagnostic tools, the present study propose to look for the predictive factors of an early fitting by noninvasive ventilation.Study Status:
Recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
Diagnostic Test
Intervention Name:
diagnosis variables
Placebo:
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
Marion Dupuis, MD, University Hospital, Toulouse
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Marion Dupuis, MD / email hidden; JavaScript is required / 5 67 77 16 91
Full Study Summary:
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.
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 Sponsor:
University Hospital, Toulouse
Estimated Enrollment:
100
Estimated Study Start Date:
12 / 14 / 2017
Estimated Study Completion Date:
12 / 14 / 2022
Posting Last Modified Date:
09 / 01 / 2021
Date Study Added to neals.org:
03 / 02 / 2018
Minimum Age:
18 Years
Maximum Age:
N/A
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
University Hospital Toulouse | Recruiting
Marion Dupuis, MD / 5 67 77 16 91 Ext. 33 / email hidden; JavaScript is required
Toulouse 31052
France