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

Primary Purpose

Neuromuscular Disorder, Respiratory Failure, Swallowing

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Spontaneous breathing
Elysée 150®
Sponsored by
Centre d'Investigation Clinique et Technologique 805
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Neuromuscular Disorder focused on measuring Neuromuscular disorder, Respiratory failure, Swallowing, Mechanical ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Raymond Poincare Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

neuromuscular patients

Arm Description

Neuromuscular non invasively ventilated patients in stable at the time of the study

Outcomes

Primary Outcome Measures

impact of non invasive ventilation on swallowing efficiency
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
Number of swallows followed by expiration
Respiratory comfort
Evaluation of the respiratory comfort by the Borg dypnea scale

Full Information

First Posted
January 23, 2012
Last Updated
July 9, 2013
Sponsor
Centre d'Investigation Clinique et Technologique 805
Collaborators
Adep Assistance
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1. Study Identification

Unique Protocol Identification Number
NCT01519388
Brief Title
Evaluation of the Impact on Swallowing of Non Invasive Ventilation
Acronym
OPTIDEG
Official Title
Evaluation of Nasal Ventilation on Optimizing Swallowing in Ventilated Neuromuscular Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre d'Investigation Clinique et Technologique 805
Collaborators
Adep Assistance

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromuscular Disorder, Respiratory Failure, Swallowing, Mechanical Ventilation
Keywords
Neuromuscular disorder, Respiratory failure, Swallowing, Mechanical ventilation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
neuromuscular patients
Arm Type
Experimental
Arm Description
Neuromuscular non invasively ventilated patients in stable at the time of the study
Intervention Type
Other
Intervention Name(s)
Spontaneous breathing
Intervention Description
study of the swallowing of boluses of water and yogurt under spontaneous breathing
Intervention Type
Device
Intervention Name(s)
Elysée 150®
Intervention Description
Study of the swallowing of boluses of water and yogurt while under mechanical ventilation
Primary Outcome Measure Information:
Title
impact of non invasive ventilation on swallowing efficiency
Description
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
Time Frame
2 Hours
Secondary Outcome Measure Information:
Title
Swallow and respiration synchronisation
Description
Number of swallows followed by expiration
Time Frame
2 Hours
Title
Respiratory comfort
Description
Evaluation of the respiratory comfort by the Borg dypnea scale
Time Frame
2 Hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helene PRIGENT, Md-PhD
Organizational Affiliation
Raymond Poincare Hospital - Garches - France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Frederic LOFASO, MD-PhD
Organizational Affiliation
Raymond Poincare Hospital - Garches - France
Official's Role
Study Director
Facility Information:
Facility Name
Raymond Poincare Hospital
City
Garches
ZIP/Postal Code
92380
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
22113817
Citation
Prigent H, Lejaille M, Terzi N, Annane D, Figere M, Orlikowski D, Lofaso F. Effect of a tracheostomy speaking valve on breathing-swallowing interaction. Intensive Care Med. 2012 Jan;38(1):85-90. doi: 10.1007/s00134-011-2417-8. Epub 2011 Nov 24.
Results Reference
background
PubMed Identifier
20558065
Citation
Terzi N, Prigent H, Lejaille M, Falaize L, Annane D, Orlikowski D, Lofaso F. Impact of tracheostomy on swallowing performance in Duchenne muscular dystrophy. Neuromuscul Disord. 2010 Aug;20(8):493-8. doi: 10.1016/j.nmd.2010.05.009. Epub 2010 Jun 16.
Results Reference
background
PubMed Identifier
17110642
Citation
Terzi N, Orlikowski D, Aegerter P, Lejaille M, Ruquet M, Zalcman G, Fermanian C, Raphael JC, Lofaso F. Breathing-swallowing interaction in neuromuscular patients: a physiological evaluation. Am J Respir Crit Care Med. 2007 Feb 1;175(3):269-76. doi: 10.1164/rccm.200608-1067OC. Epub 2006 Nov 16.
Results Reference
background
PubMed Identifier
26938617
Citation
Garguilo M, Lejaille M, Vaugier I, Orlikowski D, Terzi N, Lofaso F, Prigent H. Noninvasive Mechanical Ventilation Improves Breathing-Swallowing Interaction of Ventilator Dependent Neuromuscular Patients: A Prospective Crossover Study. PLoS One. 2016 Mar 3;11(3):e0148673. doi: 10.1371/journal.pone.0148673. eCollection 2016.
Results Reference
derived

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Evaluation of the Impact on Swallowing of Non Invasive Ventilation

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