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Completed

NCT Number: NCT01518075

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

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)

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Decompensated COPD With (Acute) Exacerbation Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, Caen

Caen, 14000, France

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spontaneous breathing

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.

Other names: SB

Non Invasive Mechanical Ventilation

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.

Other names: NIV

Primary outcomes

  1. Impact of non invasive mechanical ventilation on breathing swallowing interaction

    Time frame: 2 h

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

Secondary outcomes

  1. Correlation between breathing swallowing interaction and functional respiratory parameters

    Time frame: 24 h

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 25, 2012
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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