Evaluation of the Impact on Swallowing of Non Invasive Ventilation

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.

Conditions

• Neuromuscular Disorder
• Respiratory Failure
• Swallowing
• Mechanical Ventilation

Interventions

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

Sponsors & Collaborators

• Adep Assistance

  collaborator OTHER

• Centre d'Investigation Clinique et Technologique 805

  lead OTHER

Principal Investigators

• Helene PRIGENT, Md-PhD · Raymond Poincare Hospital - Garches - France

• Frederic LOFASO, MD-PhD · Raymond Poincare Hospital - Garches - France

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-02-29

Primary Completion

2012-02-29

Completion

2013-05-31

Countries

• France

Study Locations