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Completed

NCT Number: NCT01519388

Evaluation of the Impact on Swallowing of Non Invasive Ventilation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Raymond Poincare Hospital

Garches, 92380, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spontaneous breathing

Other

study of the swallowing of boluses of water and yogurt under spontaneous breathing

Elysée 150®

Device

Study of the swallowing of boluses of water and yogurt while under mechanical ventilation

Primary outcomes

  1. impact of non invasive ventilation on swallowing efficiency

    Time frame: 2 Hours

    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 outcomes

  1. Swallow and respiration synchronisation

    Time frame: 2 Hours

    Number of swallows followed by expiration

  2. Respiratory comfort

    Time frame: 2 Hours

    Evaluation of the respiratory comfort by the Borg dypnea scale

Sponsors and collaborators

Lead sponsor

Centre d'Investigation Clinique et Technologique 805

Other

Collaborators

  • Adep Assistance

Registry information

Official study title

Evaluation of Nasal Ventilation on Optimizing Swallowing in Ventilated Neuromuscular Patients

Acronym: OPTIDEG

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Jan 26, 2012
Registry last updated
Jul 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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