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

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD), Decompensated COPD With (Acute) Exacerbation

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Spontaneous Breathing
Non Invasive Mechanical Ventilation
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring Chronic Obstructive Pulmonary Disease, Non invasive mechanical ventilation, Breathing-swallowing interaction, Intensive Care Unit

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Hospital, Caen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Non invasive mechanical ventilation

Spontaneous Breathing

Arm Description

Evaluation of breathing swallowing interaction under non invasive mechanical ventilation

Evaluation of breathing swallowing interaction without non invasive mechanical ventilation

Outcomes

Primary Outcome Measures

Impact of non invasive mechanical ventilation on breathing swallowing interaction
Physiological evaluation of breathing - swallowing interaction with or without non invasive mechanical ventilation

Secondary Outcome Measures

Correlation between breathing swallowing interaction and functional respiratory parameters

Full Information

First Posted
January 21, 2012
Last Updated
September 14, 2012
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT01518075
Brief Title
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

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non invasive mechanical ventilation
Arm Type
Experimental
Arm Description
Evaluation of breathing swallowing interaction under non invasive mechanical ventilation
Arm Title
Spontaneous Breathing
Arm Type
Active Comparator
Arm Description
Evaluation of breathing swallowing interaction without non invasive mechanical ventilation
Intervention Type
Other
Intervention Name(s)
Spontaneous Breathing
Other Intervention Name(s)
SB
Intervention Description
Evaluation of breathing - swallowing interaction without non invasive mechanical ventilation. Patient breath spontaneously. Measurements of respiratory and swallowing parameters were monitored using respiratory inductive plethysmography. Swallowing was monitored noninvasively. Two bolus sizes were used, (5, 10 ml), in random order. Five sets of two boluses were studied, taking care not to use the same bolus size twice consecutively. The study participants were blinded to bolus size.
Intervention Type
Other
Intervention Name(s)
Non Invasive Mechanical Ventilation
Other Intervention Name(s)
NIV
Intervention Description
Evaluation of breathing - swallowing interaction with non invasive mechanical ventilation. Patient breath under non invasive mechanical ventilation. Measurements of respiratory and swallowing parameters were monitored using respiratory inductive plethysmography. Swallowing was monitored noninvasively. Two bolus sizes were used, (5, 10 ml), in random order. Five sets of two boluses were studied, taking care not to use the same bolus size twice consecutively. The study participants were blinded to bolus size.
Primary Outcome Measure Information:
Title
Impact of non invasive mechanical ventilation on breathing swallowing interaction
Description
Physiological evaluation of breathing - swallowing interaction with or without non invasive mechanical ventilation
Time Frame
2 h
Secondary Outcome Measure Information:
Title
Correlation between breathing swallowing interaction and functional respiratory parameters
Time Frame
24 h

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas TERZI, MD - PhD
Organizational Affiliation
University Hospital, Caen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Frédéric Lofaso, MD-PhD
Organizational Affiliation
University Hospital, Garches
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, Caen
City
Caen
ZIP/Postal Code
14000
Country
France

12. IPD Sharing Statement

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

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