Evaluation of the Impact on Swallowing of Non Invasive Ventilation

Not Applicable

Completed

• Conditions: Mechanical Ventilation; Neuromuscular Disorder; Swallowing; Respiratory Failure
• Interventions: Other: Spontaneous breathing; Device: Elysée 150®

• Registration Number: NCT01519388
• Lead Sponsor: Centre d'Investigation Clinique et Technologique 805

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

Study Timeline

• Study First Submitted: 2012-01-23
• Study First Submitted QC: 2012-01-25
• Study First Posted: 2012-01-26
• Study Start: 2012-02
• Primary Completion: 2012-02
• Study Completion: 2013-05
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-09
• Last Update Posted: 2013-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
neuromuscular patients	Elysée 150®	Neuromuscular non invasively ventilated patients in stable at the time of the study
neuromuscular patients	Spontaneous breathing	Neuromuscular non invasively ventilated patients in stable at the time of the study

Primary Outcome Measures

Name	Time	Method
impact of non invasive ventilation on swallowing efficiency	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 Outcome Measures

Name	Time	Method
Swallow and respiration synchronisation	2 Hours	Number of swallows followed by expiration
Respiratory comfort	2 Hours	Evaluation of the respiratory comfort by the Borg dypnea scale

Trial Locations

Locations (1)

Raymond Poincare Hospital; 🇫🇷 Garches, France