Prognostic Value of a Diaphragmatic Endurance Test in Patients With Amyotrophic Lateral Sclerosis

NCT ID: NCT02528071

Last Updated: 2021-01-05

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 136 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-09-29
• Study Completion Date: 2020-10-28

Brief Summary

Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease which involves respiratory muscles and can lead at short term to respiratory failure. The occurrence of respiratory failure is associated with morbidity and an increased mortality. To date, respiratory muscle weakness is predicted from the reduction of vital capacity, maximal inspiratory force, nocturnal symptoms and hypercapnia. Even taken together, the predictive value of these indices is low.

The investigators hypothesize that an endurance test of diaphragmatic work would be more sensitive to respiratory muscle involvement than maximal respiratory force.

Consequently, the investigators assessed diaphragmatic performance through an isocapnic hyperventilation test (IHT) in patients at the onset of ALS and, then regularly up to the occurrence of respiratory failure. The investigators make the hypothesis that IHT will be altered earlier than maximal inspiratory force

Conditions

ALS (Amyotrophic Lateral Sclerosis)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients

ALS patients performing measurements of maximal respiratory forces, diaphragmatic endurance during a diaphragmatic endurance test and phrenic nerve activity at the onset of the disease and repeated every 3 months up to respiratory failure or death

Diaphragmatic endurance test

Intervention Type: OTHER

This consists of hyperventilation in a flask while maintaining the constant level of Carbon Dioxide (CO2). The patient will realize hyperventilation to increasing levels of Maximum Minute Ventilation (MMV), corresponding to increasing levels of respiratory rate, until exhaustion

Control

Healthy controls performing measurements of maximal respiratory forces, diaphragmatic endurance during a diaphragmatic endurance test and phrenic nerve activity. This arm will enable to establish reference values of IHT

Diaphragmatic endurance test

Intervention Type: OTHER

This consists of hyperventilation in a flask while maintaining the constant level of Carbon Dioxide (CO2). The patient will realize hyperventilation to increasing levels of Maximum Minute Ventilation (MMV), corresponding to increasing levels of respiratory rate, until exhaustion

Interventions

Diaphragmatic endurance test

This consists of hyperventilation in a flask while maintaining the constant level of Carbon Dioxide (CO2). The patient will realize hyperventilation to increasing levels of Maximum Minute Ventilation (MMV), corresponding to increasing levels of respiratory rate, until exhaustion

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Older than 18 years old and younger than 80 years old
• ALS patient seen during the diagnostic assessment

• Older than 25 years old and younger than 80 years old
• No respiratory or neurologic active pathology

Exclusion Criteria

• Bulbar ALS (inability to perform maximal respiratory maneuvers)
• Dementia
• Respiratory failure at diagnosis (arterial carbon dioxide partial pressure (pCO2) > 45 mmHg)
• Respiratory or neurologic active pathology

• Chest wall deformation with spirometric defect

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frederic COSTES, MD PhD

Role: STUDY_CHAIR

CHU de Clermont-Ferrand

Isabelle COURT-FORTUNE, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Etienne

Locations

CHU de SAINT-ETIENNE

Saint-Etienne, , France

Countries

France

Other Identifiers

2014-A00309-38

Identifier Type: OTHER

Identifier Source: secondary_id

1308188

Identifier Type: -

Identifier Source: org_study_id