Predictive Factors for the Diagnosis of Early Noninvasive Ventilation Equipment

NCT03452618 | Unknown

• 2 other identifiers: RC31/17/02012017-A02202-51
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

diagnostic criteria

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Sensitivity, specificity, negative and positive predictive values

  One year after the diagnostic

• Percentage of decrease

  One year after the diagnostic

• Slope of FVC decline

  One year after the diagnostic

• Quality of life score

  One year after the diagnostic

Study Arms (2)

patients with a NIV equipment

EXPERIMENTAL

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

Diagnostic Test: diagnosis variables

patients without a NIV equipment

ACTIVE COMPARATOR

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

Diagnostic Test: diagnosis variables

Interventions

diagnosis variables DIAGNOSTIC_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)

patients with a NIV equipment; patients without a NIV equipment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital Toulouse

Toulouse, 31052, France

RECRUITING

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Marion Dupuis, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study compare the diagnostic's variables in patients who received NIV one year after diagnosis and those who did not.

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 2, 2018
• Study Start: December 14, 2017
• Primary Completion: December 14, 2021
• Study Completion: December 14, 2022
• Last Updated: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)