Breathing-swallowing Interaction in Chronic Obstructive Pulmonary Disease Patients - Impact of Non Invasive Ventilation

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD); Decompensated COPD With (Acute) Exacerbation
• Interventions: Other: Non Invasive Mechanical Ventilation; Other: Spontaneous Breathing

• Registration Number: NCT01518075
• Lead Sponsor: University Hospital, Caen

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)

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-21
• Study First Submitted QC: 2012-01-21
• Study First Posted: 2012-01-25
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-14
• Last Update Posted: 2012-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non invasive mechanical ventilation	Non Invasive Mechanical Ventilation	Evaluation of breathing swallowing interaction under non invasive mechanical ventilation
Spontaneous Breathing	Spontaneous Breathing	Evaluation of breathing swallowing interaction without non invasive mechanical ventilation

Primary Outcome Measures

Name	Time	Method
Impact of non invasive mechanical ventilation on breathing swallowing interaction	2 h	Physiological evaluation of breathing - swallowing interaction with or without non invasive mechanical ventilation

Secondary Outcome Measures

Name	Time	Method
Correlation between breathing swallowing interaction and functional respiratory parameters	24 h

Trial Locations

Locations (1)

University Hospital, Caen; 🇫🇷 Caen, France