Skip to main content
OpenTrials
Completed

NCT Number: NCT01819090

Optimizing Communication During 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neuromuscular Disorder Behavior Communication Nervous System Diseases Neuromuscular Diseases Respiration Disorders Respiratory Failure Respiratory Insufficiency Respiratory Tract Diseases Speech Verbal Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Raymond Poincare

Garches, 92380, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Elysee 150 ventilator

Device

Other names: Elysee 150 - Resmed

Elysee 150 ventilator with a ventilation switch control

Device

Other names: Elysee 150 ventilator - Resmed - with a ventilation switch control

Primary outcomes

  1. Impact of patient's ventilation control on speech efficiency

    Time frame: 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 outcomes

  1. Patient ventilator synchronisation during speech

    Time frame: 1hour 30 min

    Evaluated with the variation of respiratory frequency during speech, the number of auto-triggered ventilation cycles during speech.

  2. User friendliness of the ventilator during speech

    Time frame: 1hour 30 min

    evaluation of user friendliness by the patient using a visual analogical score

  3. Respiratory comfort during speech

    Time frame: 1hour 30 min

    evaluation of user friendliness by the patient using a visual analogical score and the Borg score

  4. Speech comfort during ventilation

    Time frame: 1hour 30 min

    evaluation of speech comfort during ventilation by the patient using a visual analogical score

Sponsors and collaborators

Lead sponsor

Centre d'Investigation Clinique et Technologique 805

Other

Registry information

Official study title

Optimizing Communication During Nasal Mechanical Ventilation

Acronym: PHONOVNI

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 27, 2013
Registry last updated
Feb 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.