Optimizing Communication During Ventilation (PHONOVNI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Helene Prigent, Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier:
NCT01819090
First received: March 7, 2013
Last updated: February 12, 2016
Last verified: October 2015
  Purpose
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.

Condition Intervention
Neuromuscular Disorder
Respiratory Failure
Device: Elysee 150 ventilator
Device: Elysee 150 ventilator with a ventilation switch control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Optimizing Communication During Nasal Mechanical Ventilation

Resource links provided by NLM:


Further study details as provided by Centre d'Investigation Clinique et Technologique 805:

Primary Outcome Measures:
  • Impact of patient's ventilation control on speech efficiency [ Time Frame: 1 hour 30 min ] [ Designated as safety issue: No ]
    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:
  • Patient ventilator synchronisation during speech [ Time Frame: 1hour 30 min ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1hour 30 min ] [ Designated as safety issue: No ]
    evaluation of user friendliness by the patient using a visual analogical score

  • Respiratory comfort during speech [ Time Frame: 1hour 30 min ] [ Designated as safety issue: No ]
    evaluation of user friendliness by the patient using a visual analogical score and the Borg score

  • Speech comfort during ventilation [ Time Frame: 1hour 30 min ] [ Designated as safety issue: No ]
    evaluation of speech comfort during ventilation by the patient using a visual analogical score


Enrollment: 10
Study Start Date: November 2013
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Elysee 150 ventilator - Resmed - with a ventilation switch control

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01819090

Locations
France
Hopital Raymond Poincare
Garches, France, 92380
Sponsors and Collaborators
Centre d'Investigation Clinique et Technologique 805
Investigators
Principal Investigator: Helene PRIGENT, MDPHD Hôpital RAYMOND POINCARE
  More Information

Responsible Party: Helene Prigent, MDPHD, Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier: NCT01819090     History of Changes
Other Study ID Numbers: 2012- A01394-39 
Study First Received: March 7, 2013
Last Updated: February 12, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre d'Investigation Clinique et Technologique 805:
Neuromuscular disorder
Mechanical ventilation
Speech
Respiratory failure

Additional relevant MeSH terms:
Respiratory Insufficiency
Neuromuscular Diseases
Respiration Disorders
Respiratory Tract Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 24, 2016