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

Primary Purpose

Amyotrophic Lateral Sclerosis

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
diagnosis variables
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Amyotrophic Lateral Sclerosis focused on measuring diagnostic criteria

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospital ToulouseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

patients with a NIV equipment

patients without a NIV equipment

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
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
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
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.

Full Information

First Posted
February 26, 2018
Last Updated
August 26, 2021
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT03452618
Brief Title
Predictive Factors for the Diagnosis of Early Noninvasive Ventilation Equipment
Acronym
PREDAPP
Official Title
Predictive Factors for the Diagnosis of Early Noninvasive Ventilation Equipment in Patients With Amyotrophic Lateral Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 14, 2017 (Actual)
Primary Completion Date
December 14, 2021 (Anticipated)
Study Completion Date
December 14, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
Keywords
diagnostic criteria

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study compare the diagnostic's variables in patients who received NIV one year after diagnosis and those who did not.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patients with a NIV equipment
Arm Type
Experimental
Arm Description
Determination of diagnosis variables in a group of patient who benefit of the Non Invasive ventilation equipment one year after the diagnostic
Arm Title
patients without a NIV equipment
Arm Type
Active Comparator
Arm Description
Determination of diagnosis variables in a group of patient who not benefit of the Non Invasive ventilation equipment one year after the diagnostic
Intervention Type
Diagnostic Test
Intervention Name(s)
diagnosis variables
Intervention Description
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)
Primary Outcome Measure Information:
Title
Early Surgical Clinical Score
Description
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)
Time Frame
One year after diagnostic
Secondary Outcome Measure Information:
Title
Sensitivity, specificity, negative and positive predictive values
Description
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
Time Frame
One year after the diagnostic
Title
Percentage of decrease
Description
% decrease in shortening fraction and diaphragmatic stroke between two quarterly reevaluations correlated with early fitting and % decrease in FVC, SNIP test et Pimax
Time Frame
One year after the diagnostic
Title
Slope of FVC decline
Description
Slope of FVC decline before and after NIV implementation and slope of decline of shortening fraction and diaphragmatic stroke before and after NIV
Time Frame
One year after the diagnostic
Title
Quality of life score
Description
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.
Time Frame
One year after the diagnostic

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marion Dupuis, MD
Phone
5 67 77 16 91
Ext
33
Email
dupuis.m@chu-toulouse.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle Olivier, PhD
Phone
5 61 77 70 51
Ext
33
Email
olivier.i@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marion Dupuis, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Toulouse
City
Toulouse
ZIP/Postal Code
31052
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marion Dupuis, MD
Phone
5 67 77 16 91
Ext
33
Email
dupuis.m@chu-toulouse.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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Predictive Factors for the Diagnosis of Early Noninvasive Ventilation Equipment

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