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

NCT ID: NCT01518075

Last Updated: 2012-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-08-31

Brief Summary

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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

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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)

Conditions

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

Keywords

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Chronic Obstructive Pulmonary Disease Non invasive mechanical ventilation Breathing-swallowing interaction Intensive Care Unit

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Non invasive mechanical ventilation

Evaluation of breathing swallowing interaction under non invasive mechanical ventilation

Group Type EXPERIMENTAL

Non Invasive Mechanical Ventilation

Intervention Type OTHER

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.

Spontaneous Breathing

Evaluation of breathing swallowing interaction without non invasive mechanical ventilation

Group Type ACTIVE_COMPARATOR

Spontaneous Breathing

Intervention Type OTHER

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.

Interventions

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Spontaneous Breathing

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

Non Invasive Mechanical Ventilation

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.

Intervention Type OTHER

Other Intervention Names

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SB NIV

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicolas TERZI, MD - PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Caen

Frédéric Lofaso, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Garches

Locations

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University Hospital, Caen

Caen, , France

Site Status

Countries

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France

Other Identifiers

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DEGLUT

Identifier Type: -

Identifier Source: org_study_id