Evaluation of the Impact on Swallowing of Non Invasive Ventilation (OPTIDEG)

This study has been completed.
Sponsor:
Collaborator:
Adep Assistance
Information provided by (Responsible Party):
Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier:
NCT01519388
First received: January 23, 2012
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

Neuromuscular disorders can be associated with swallowing dysfunction secondary to a dysfunction of the airway muscles involved in swallowing. The investigators have shown that respiratory failure may contribute to swallowing dysfunction in patients with neuromuscular respiratory failure. Furthermore, although tracheostomy has been reported as impairing swallowing, the investigators have shown that when a tracheostomy is performed in neuromuscular patients, swallowing improves because it allows the patient to feed while ventilated.

The investigators now want to evaluate whether non invasive ventilation may have a beneficial impact on swallowing by making some adjustments to ensure a good synchronisation between ventilation and swallowing. This could allow avoiding the necessity of a tracheostomy or a gastrostomy due to swallowing dysfunction and/or malnutrition in neuromuscular patients.

Swallowing improvement under mechanical ventilation depends on improving the synchronisation between the patient and the ventilator during swallowing. For that purpose, the investigators developed a prototype ventilator able to temporarily suspend pressurisation under the patient's control so that when the patient needs to swallow under mechanical ventilation he may do so with an inadequate insufflation of the ventilator.

Our objective is to to demonstrate that swallowing is more adapted and easier under nasal noninvasive ventilation than during spontaneous breathing in neuromuscular patients requiring prolonged noninvasive ventilation.

In an open monocentric pilot study, the investigators will study 10 neuromuscular patients usually noninvasively ventilated. The patients will be their own control and their swallow will be studied during spontaneous breathing and under ventilation with the adapted ventilator while swallowing boluses of different volumes.


Condition Intervention
Neuromuscular Disorder
Respiratory Failure
Swallowing
Mechanical Ventilation
Other: Spontaneous breathing
Device: Elysée 150®

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Evaluation of Nasal Ventilation on Optimizing Swallowing in Ventilated Neuromuscular Patients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • impact of non invasive ventilation on swallowing efficiency [ Time Frame: 2 Hours ] [ Designated as safety issue: No ]
    Swallowing efficiency under non invasive ventilation will be evaluated by the duration of swallowing of bolus, number of swallow per bolus, number of respiratory cycles per swallowed bolus


Secondary Outcome Measures:
  • Swallow and respiration synchronisation [ Time Frame: 2 Hours ] [ Designated as safety issue: No ]
    Number of swallows followed by expiration

  • Respiratory comfort [ Time Frame: 2 Hours ] [ Designated as safety issue: No ]
    Evaluation of the respiratory comfort by the Borg dypnea scale


Enrollment: 10
Study Start Date: February 2012
Study Completion Date: May 2013
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: neuromuscular patients
Neuromuscular non invasively ventilated patients in stable at the time of the study
Other: Spontaneous breathing
study of the swallowing of boluses of water and yogurt under spontaneous breathing
Device: Elysée 150®
Study of the swallowing of boluses of water and yogurt while under mechanical ventilation

Detailed Description:

Neuromuscular disorders can be associated with swallowing dysfunction secondary to a dysfunction of airway muscles involved in swallowing. We have shown that respiratory failure may also contribute to swallowing dysfunction and that, although tracheostomy has been reported as impairing swallowing, when a tracheostomy was performed in neuromuscular patients, swallowing was improved because it allowed the patient to feed while ventilated.

We now want to evaluate whether non invasive ventilation may have a beneficial impact on swallowing considering some adjustments to ensure a good synchronisation between ventilation and swallowing. This could allow avoiding the necessity of a tracheostomy or a gastrostomy due to swallowing dysfunction and/or malnutrition. Improving swallowing under mechanical ventilation depends on improving the synchronisation between the patient and the ventilator during swallowing. For that purpose, we developed a prototype ventilator able to temporarily suspend pressurisation under the patient's control so that when the patient needs to swallow under mechanical ventilation he may do so with an inadequate insufflation of the ventilator.

Our objective is to to demonstrate that swallowing is more adapted and easier under nasal noninvasive ventilation than during spontaneous breathing in neuromuscular patients requiring prolonged noninvasive ventilation.

In an open monocentric pilot study, we will study 10 neuromuscular patients usually noninvasively ventilated. The patients will be their own control and their swallow will be studied during spontaneous breathing and under ventilation with the adapted ventilator while swallowing boluses of different volumes. Swallowing will be evaluated by measuring swallowing duration, numbers of swallows required for a bolus, number of respiratory cycles required for the swallow of a bolus. Order ventilation mode and bolus volume will be randomized

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Neurologic or Neuromuscular restrictive respiratory failure, excluding bulbar involvement
  • Hospitalization in the home ventilation unit of the Raymond Poincaré Hospital
  • day and night non invasive ventilation during >14hours/day
  • respiratory autonomy of at least one hour of during the day
  • Ventilation with an assisted and controled mode
  • Adults ≥18 years
  • Stable patient upon inclusion
  • prior Medical examination
  • Signed consent form

Exclusion Criteria:

  • Unstable hemodynamics
  • Respiratory decompensation
  • Unable to cooperate
  • Person under guardianship or trusteeship
  • Pregnant women
  • Refusal of study participation
  • Non covered by the social security system
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01519388

Locations
France
Raymond Poincare Hospital
Garches, France, 92380
Sponsors and Collaborators
Centre d'Investigation Clinique et Technologique 805
Adep Assistance
Investigators
Principal Investigator: Helene PRIGENT, Md-PhD Raymond Poincare Hospital - Garches - France
Study Director: Frederic LOFASO, MD-PhD Raymond Poincare Hospital - Garches - France
  More Information

Publications:
Responsible Party: Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier: NCT01519388     History of Changes
Other Study ID Numbers: 2011-A00771-40
Study First Received: January 23, 2012
Last Updated: July 9, 2013
Health Authority: France: Ministry of Health

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

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

ClinicalTrials.gov processed this record on August 27, 2014