Evaluation of the Impact on Swallowing of Non Invasive Ventilation

Respiratory Failure Clinical Trial

— OPTIDEG  

Official title:

Evaluation of Nasal Ventilation on Optimizing Swallowing in Ventilated Neuromuscular Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01519388
• Other study ID #: 2011-A00771-40
• Status: Completed
• Phase: N/A
• First received: January 23, 2012
• Last updated: July 9, 2013
• Start date: February 2012
• Est. completion date: May 2013

Study information

• Verified date: July 2013
• Source: Centre d'Investigation Clinique et Technologique 805
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2013
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Mechanical Ventilation
• Neuromuscular Diseases
• Neuromuscular Disorder
• Respiratory Failure
• Respiratory Insufficiency
• Swallowing

Intervention

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

Locations

Country	Name	City	State
France	Raymond Poincare Hospital	Garches

Sponsors (2)

Lead Sponsor	Collaborator
Centre d'Investigation Clinique et Technologique 805	Adep Assistance

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View 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. Epub 2006 Nov 16. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 Hours	No
Secondary	Swallow and respiration synchronisation	Number of swallows followed by expiration	2 Hours	No
Secondary	Respiratory comfort	Evaluation of the respiratory comfort by the Borg dypnea scale	2 Hours	No