Predictive Factors for the Diagnosis of Early Noninvasive Ventilation Equipment (PREDAPP)

Toulouse University Hospital

Status: Unknown

Conditions: Amyotrophic Lateral Sclerosis

Treatments: Diagnostic Test: diagnosis variables

Study type: Interventional

Funder types: Other

Identifiers

NCT03452618

RC31/17/0201

2017-A02202-51 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

patients with a NIV equipment

Experimental group

Description:

Determination of diagnosis variables in a group of patient who benefit of the Non Invasive ventilation equipment one year after the diagnostic

Treatment:

Diagnostic Test: diagnosis variables

patients without a NIV equipment

Active Comparator group

Description:

Determination of diagnosis variables in a group of patient who not benefit of the Non Invasive ventilation equipment one year after the diagnostic

Treatment:

Diagnostic Test: diagnosis variables