NCT01819090

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2013

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 27, 2013

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

February 15, 2016

Status Verified

October 1, 2015

Enrollment Period

1.3 years

First QC Date

March 7, 2013

Last Update Submit

February 12, 2016

Conditions

Neuromuscular DisorderRespiratory Failure

Keywords

Neuromuscular disorderMechanical ventilationSpeechRespiratory failure

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Patient ventilator synchronisation during speech

    1hour 30 min

  • User friendliness of the ventilator during speech

    1hour 30 min

  • Respiratory comfort during speech

    1hour 30 min

  • Speech comfort during ventilation

    1hour 30 min

Study Arms (2)

No ventilation switch control

ACTIVE COMPARATOR

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

Ventilation switch control

ACTIVE COMPARATOR

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

Interventions

Elysee 150 ventilatorDEVICE
Also known as: Elysee 150 - Resmed
No ventilation switch control
Elysee 150 ventilator with a ventilation switch controlDEVICE
Also known as: Elysee 150 ventilator - Resmed - with a ventilation switch control
Ventilation switch control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Raymond Poincare

Garches, Garches, 92380, France

Location

MeSH Terms

Conditions

Neuromuscular DiseasesRespiratory InsufficiencySpeech

Condition Hierarchy (Ancestors)

Nervous System DiseasesRespiration DisordersRespiratory Tract DiseasesVerbal BehaviorCommunicationBehavior

Study Officials

  • Helene PRIGENT, MDPHD

    Hôpital RAYMOND POINCARE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MDPHD

Study Record Dates

First Submitted

March 7, 2013

First Posted

March 27, 2013

Study Start

November 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

February 15, 2016

Record last verified: 2015-10

Locations

FR(1)