Optimizing Communication During Ventilation (PHONOVNI)

Optimizing Communication During Nasal Mechanical Ventilation

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Failure; Neuromuscular Disorder
• Intervention / Treatment: Device: Elysee 150 ventilator; Device: Elysee 150 ventilator with a ventilation switch control

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Garches, France, 92380
    • Hôpital Raymond Poincaré

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: No ventilation switch control; 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; Other Names: Elysee 150 - Resmed
Active Comparator: 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	Device: Elysee 150 ventilator with a ventilation switch control; 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

Collaborators and Investigators

• Sponsor: Centre d'Investigation Clinique et Technologique 805
• Investigators: Principal Investigator: Helene PRIGENT, MDPHD, Hôpital Raymond Poincaré

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: March 7, 2013
• First Submitted That Met QC Criteria: March 22, 2013
• First Posted (Estimate): March 27, 2013

Study Record Updates

• Last Update Posted (Estimate): February 15, 2016
• Last Update Submitted That Met QC Criteria: February 12, 2016
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Respiratory failure; Speech; Mechanical ventilation; Neuromuscular disorder
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Neuromuscular Diseases
• Other Study ID Numbers: 2012- A01394-39