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

Purpose

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)

Condition	Intervention
Chronic Obstructive Pulmonary Disease (COPD) Decompensated COPD With (Acute) Exacerbation	Other: Spontaneous Breathing Other: Non Invasive Mechanical Ventilation

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science
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

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Drug Reactions

U.S. FDA Resources

Further study details as provided by University Hospital, Caen:

Primary Outcome Measures:

Impact of non invasive mechanical ventilation on breathing swallowing interaction [ Time Frame: 2 h ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 24 h ] [ Designated as safety issue: No ]

Enrollment:	16
Study Start Date:	January 2012
Study Completion Date:	August 2012
Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Non invasive mechanical ventilation Evaluation of breathing swallowing interaction under non invasive mechanical ventilation	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. Other Name: NIV
Active Comparator: Spontaneous Breathing Evaluation of breathing swallowing interaction without non invasive mechanical ventilation	Other: 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. Other Name: SB

Arms

Assigned Interventions

Experimental: Non invasive mechanical ventilation

Evaluation of breathing swallowing interaction under non invasive mechanical ventilation

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.

Other Name: NIV

Active Comparator: Spontaneous Breathing

Evaluation of breathing swallowing interaction without non invasive mechanical ventilation

Other: 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.

Other Name: SB

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01518075

Locations

France
University Hospital, Caen
Caen, France, 14000

Sponsors and Collaborators

University Hospital, Caen

Investigators

Principal Investigator:	Nicolas TERZI, MD - PhD	University Hospital, Caen
Principal Investigator:	Frédéric Lofaso, MD-PhD	University Hospital, Garches

More Information

No publications provided

Responsible Party:	University Hospital, Caen
ClinicalTrials.gov Identifier:	NCT01518075 History of Changes
Other Study ID Numbers:	DEGLUT
Study First Received:	January 21, 2012
Last Updated:	September 14, 2012
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Caen:

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

Additional relevant MeSH terms:

Respiratory Aspiration
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive

Lung Diseases, Obstructive
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013