Evaluation of the Impact on Swallowing of Non Invasive Ventilation

NCT01519388 | Completed

• 1 other identifier: 2011-A00771-40
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuromuscular Disorder; Respiratory Failure; Swallowing; Mechanical Ventilation

Keywords

Neuromuscular disorder; Respiratory failure; Swallowing; Mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Swallow and respiration synchronisation

  2 Hours

• Respiratory comfort

  2 Hours

Study Arms (1)

neuromuscular patients

EXPERIMENTAL

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

Other: Spontaneous breathing; Device: Elysée 150®

Interventions

Spontaneous breathing OTHER

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

neuromuscular patients

Elysée 150® DEVICE

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

neuromuscular patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• prior Medical examination
• Signed consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre d'Investigation Clinique et Technologique 805: lead
• Adep Assistance: collaborator

Study Sites (1)

Raymond Poincare Hospital

Garches, Garches, 92380, France

Location

Related Publications (4)

• 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.

  PMID: 22113817 BACKGROUND

• 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.

  PMID: 20558065 BACKGROUND

• 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.

  PMID: 17110642 BACKGROUND

• 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.

  PMID: 26938617 DERIVED

MeSH Terms

Conditions

Neuromuscular Diseases; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Nervous System Diseases; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Helene PRIGENT, Md-PhD

  Raymond Poincare Hospital - Garches - France

  PRINCIPAL INVESTIGATOR

• Frederic LOFASO, MD-PhD

  Raymond Poincare Hospital - Garches - France

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2012
• First Posted: January 26, 2012
• Study Start: February 1, 2012
• Primary Completion: February 1, 2012
• Study Completion: May 1, 2013
• Last Updated: July 10, 2013

Record last verified: 2013-07

Locations

FR (1)