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Optimizing Communication During Ventilation

Optimizing Communication During Nasal Mechanical Ventilation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01819090
Acronym
PHONOVNI
Enrollment
10
Registered
2013-03-27
Start date
2013-11-30
Completion date
2015-03-31
Last updated
2016-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromuscular Disorder, Respiratory Failure

Keywords

Neuromuscular disorder, Mechanical ventilation, Speech, Respiratory failure

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.

Interventions

DEVICEElysee 150 ventilator
DEVICEElysee 150 ventilator with a ventilation switch control

Sponsors

Centre d'Investigation Clinique et Technologique 805
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Impact of patient's ventilation control on speech efficiency1 hour 30 minSpeech 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

MeasureTime frameDescription
Patient ventilator synchronisation during speech1hour 30 minEvaluated with the variation of respiratory frequency during speech, the number of auto-triggered ventilation cycles during speech.
User friendliness of the ventilator during speech1hour 30 minevaluation of user friendliness by the patient using a visual analogical score
Respiratory comfort during speech1hour 30 minevaluation of user friendliness by the patient using a visual analogical score and the Borg score
Speech comfort during ventilation1hour 30 minevaluation of speech comfort during ventilation by the patient using a visual analogical score

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026