Optimizing Communication During Ventilation

Study Overview
=================
Brief Summary
-----------------
Mechanical ventilation is one of the only treatment that has improved survival of patients with neuromuscular respiratory failure. As disease progresses, some patients may require longer ventilation period. Non invasive mechanical ventilation is the preferred method of ventilation but it may interfere with speech and communication of patients who require ventilation throughout the day. The investigators are evaluating the effect on speech and communication of a ventilation device which allows patients to momentarily and voluntarily withhold ventilation if they want to speak. This should allow the patients to have a more fluid speech.

Official Title
-----------------
Optimizing Communication During Nasal Mechanical Ventilation

Conditions
-----------------
Neuromuscular Disorder, Respiratory Failure

Intervention / Treatment
-----------------
* Device: Elysee 150 ventilator
* Device: Elysee 150 ventilator with a ventilation switch control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with restrictive respiratory failure secondary to a neuromuscular disorder, without any bulbar involvement. Age greater than or equal to 18. Hospitalization in Home Ventilation Unit of the intensive care department of R. Poincaré Hospital. Non invasive mechanical ventilation for a duration equal or above 14h per day. Patient in a steady state at the time of the study written informed consent Exclusion Criteria: patient's refusal to participate to the study Inability to read the selected text Inability to use the ventilator switch Inability to cooperate Hemodynamic instability Acute respiratory failure No affiliation to social security

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: No ventilation switch control<br>Neuromuscular patients non invasively ventilated in a stable state at the time of the study testing an usual (with no ventilation switch control) Elysee 150 ventilator while speaking | Device: Elysee 150 ventilator<br> <br> * Other names: Elysee 150 - Resmed;|
| Active Comparator: Ventilation switch control<br>Neuromuscular patients non invasively ventilated in a stable state at the time of the study testing an Elysee 150 ventilator with a ventilation switch control allowing them to control ventilation while speaking | Device: Elysee 150 ventilator with a ventilation switch control<br> <br> * Other names: Elysee 150 ventilator - Resmed - with a ventilation switch control;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of patient's ventilation control on speech efficiency | Speech efficiency will be evaluated while using a ventilator which allows the patient to constantly control when he wants to be ventilated Speech evaluation is based on speech rhythm and text reading duration | 1 hour 30 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient ventilator synchronisation during speech | Evaluated with the variation of respiratory frequency during speech, the number of auto-triggered ventilation cycles during speech. | 1hour 30 min | 
| User friendliness of the ventilator during speech | evaluation of user friendliness by the patient using a visual analogical score | 1hour 30 min | 
| Respiratory comfort during speech | evaluation of user friendliness by the patient using a visual analogical score and the Borg score | 1hour 30 min | 
| Speech comfort during ventilation | evaluation of speech comfort during ventilation by the patient using a visual analogical score | 1hour 30 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neuromuscular disorder, Mechanical ventilation, Speech, Respiratory failure