Optimizing Communication During Ventilation (PHONOVNI)

Centre d'Investigation Clinique et Technologique 805

Status: Completed

Conditions: Respiratory Failure; Neuromuscular Disorder

Treatments: Device: Elysee 150 ventilator with a ventilation switch control; Device: Elysee 150 ventilator

Study type: Interventional

Funder types: Other

Identifiers

NCT01819090

2012- A01394-39

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

10 participants in 2 patient groups

No ventilation switch control

Active Comparator group

Description:

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

Treatment:

Device: Elysee 150 ventilator

Ventilation switch control

Active Comparator group

Description:

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

Treatment:

Device: Elysee 150 ventilator with a ventilation switch control