Optimizing Communication During Ventilation

Not Applicable

Completed

• Conditions: Respiratory Failure; Neuromuscular Disorder
• Interventions: Device: Elysee 150 ventilator with a ventilation switch control; Device: Elysee 150 ventilator

• Registration Number: NCT01819090
• Lead Sponsor: Centre d'Investigation Clinique et Technologique 805

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-07
• Study First Submitted QC: 2013-03-22
• Study First Posted: 2013-03-27
• Study Start: 2013-11
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-10
• Last Update Submitted: 2016-02-12
• Last Update Posted: 2016-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ventilation switch control	Elysee 150 ventilator with a ventilation switch control	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
No ventilation switch control	Elysee 150 ventilator	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

Primary Outcome Measures

Name	Time	Method
Impact of patient's ventilation control on speech efficiency	1 hour 30 min	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hopital Raymond Poincare; 🇫🇷 Garches, France