Back to resultsOptimizing Communication During Ventilation (PHONOVNI)
Primary Purpose
Neuromuscular Disorder, Respiratory Failure
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Elysee 150 ventilator
Elysee 150 ventilator with a ventilation switch control
Sponsored by
About this trial
This is an interventional supportive care trial for Neuromuscular Disorder focused on measuring Neuromuscular disorder, Mechanical ventilation, Speech, Respiratory failure
Eligibility 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
Sites / Locations
- Hopital Raymond Poincare
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
No ventilation switch control
Ventilation switch control
Arm 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
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Patient ventilator synchronisation during speech
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
evaluation of user friendliness by the patient using a visual analogical score
Respiratory comfort during speech
evaluation of user friendliness by the patient using a visual analogical score and the Borg score
Speech comfort during ventilation
evaluation of speech comfort during ventilation by the patient using a visual analogical score
Full Information
NCT ID
NCT01819090
First Posted
March 7, 2013
Last Updated
February 12, 2016
Sponsor
Centre d'Investigation Clinique et Technologique 805
1. Study Identification
Unique Protocol Identification Number
NCT01819090
Brief Title
Optimizing Communication During Ventilation
Acronym
PHONOVNI
Official Title
Optimizing Communication During Nasal Mechanical Ventilation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre d'Investigation Clinique et Technologique 805
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromuscular Disorder, Respiratory Failure
Keywords
Neuromuscular disorder, Mechanical ventilation, Speech, Respiratory failure
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No ventilation switch control
Arm Type
Active Comparator
Arm 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
Arm Title
Ventilation switch control
Arm Type
Active Comparator
Arm 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
Intervention Type
Device
Intervention Name(s)
Elysee 150 ventilator
Other Intervention Name(s)
Elysee 150 - Resmed
Intervention Type
Device
Intervention Name(s)
Elysee 150 ventilator with a ventilation switch control
Other Intervention Name(s)
Elysee 150 ventilator - Resmed - with a ventilation switch control
Primary Outcome Measure Information:
Title
Impact of patient's ventilation control on speech efficiency
Description
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
Time Frame
1 hour 30 min
Secondary Outcome Measure Information:
Title
Patient ventilator synchronisation during speech
Description
Evaluated with the variation of respiratory frequency during speech, the number of auto-triggered ventilation cycles during speech.
Time Frame
1hour 30 min
Title
User friendliness of the ventilator during speech
Description
evaluation of user friendliness by the patient using a visual analogical score
Time Frame
1hour 30 min
Title
Respiratory comfort during speech
Description
evaluation of user friendliness by the patient using a visual analogical score and the Borg score
Time Frame
1hour 30 min
Title
Speech comfort during ventilation
Description
evaluation of speech comfort during ventilation by the patient using a visual analogical score
Time Frame
1hour 30 min
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helene PRIGENT, MDPHD
Organizational Affiliation
Hôpital RAYMOND POINCARE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Raymond Poincare
City
Garches
ZIP/Postal Code
92380
Country
France
12. IPD Sharing Statement
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Optimizing Communication During Ventilation
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