Clinical trial NCT01518075: Breathing-swallowing Interaction in Chronic Obstructive Pulmonary Disease Patients - Impact of Non Invasive Ventilation
Official title: Breathing-swallowing Interaction in Chronic Obstructive Pulmonary Disease (COPD) Patients Hospitalized in Intensive Care Unit for an Acute Exacerbation: Impact of Non Invasive Ventilation. Physiological Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Decompensated COPD With (Acute) Exacerbation
Keywords: Chronic Obstructive Pulmonary Disease
Non invasive mechanical ventilation
Breathing-swallowing interaction
Intensive Care Unit
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2012-01-25
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In the investigators' knowledge there are no data about the impact of non invasive mechanical ventilation on the breathing-swallowing interaction.

Our main objective is to evaluate breathing-swallowing interaction in Chronic Obstructive Pulmonary Disease (COPD) patients hospitalized in intensive care unit for an acute exacerbation, and evaluate the impact of using non invasive mechanical ventilation (NIV)

Detailed description: In healthy subjects previous studies showed that most swallows started during expiration and were followed by expiration, a pattern believed to contribute to airway protection during swallowing. However In healthy individuals, the occurrence of inspiration after swallows was increased by hypercapnia or application of an inspiratory elastic load.

In a previous study the investigators have demonstrated that patients with neuromuscular disorders exhibited piecemeal deglutition leading to an increase in the time needed to swallow a water bolus, as well as occurrence of inspiration after nearly half the swallows. These abnormalities which increased with the decreasing of respiratory muscle performances may explain feeding difficulties. However in tracheostomized patients who could breathe spontaneously, piecemeal deglutition and swallowing time per bolus were diminished by the use of mechanical ventilation.

In the investigators' knowledge there are no data about the impact of non invasive mechanical ventilation on the breathing-swallowing interaction.

The investigators' main objective is to evaluate breathing-swallowing interaction in Chronic Obstructive Pulmonary Disease (COPD) patients hospitalized in intensive care unit for an acute exacerbation, and evaluate the impact of using non invasive mechanical ventilation (NIV)

Eligibility criteria: Inclusion Criteria:

* Patients with Chronic Obstructive Pulmonary Disease
* Age \> 18 years
* Hospitalized in Intensive care for an acute exacerbation
* Requiring Non invasive mechanical ventilation
* Able to breath spontaneously without non invasive ventilation more than 4h/day
* Without bulbar dysfunction

Exclusion Criteria:

* Hemodynamic instability
* Absence of consent
* Severe Hypoxemia
* pH \< 7,30
* No cooperation of the patient

Primary outcomes:
measure: Impact of non invasive mechanical ventilation on breathing swallowing interaction
timeFrame: 2 h
Secondary outcomes:
measure: Correlation between breathing swallowing interaction and functional respiratory parameters
timeFrame: 24 h
Other outcomes:
Locations:
city: Caen
country: France
facility: University Hospital, Caen
Study officials:
affiliation: University Hospital, Caen
name: Nicolas TERZI, MD - PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Garches
name: Frédéric Lofaso, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: