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

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

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)

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD); Decompensated COPD With (Acute) Exacerbation
• Intervention / Treatment: Other: Non Invasive Mechanical Ventilation; Other: Spontaneous Breathing

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, France, 14000
    • University Hospital, Caen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: SB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of non invasive mechanical ventilation on breathing swallowing interaction	Physiological evaluation of breathing - swallowing interaction with or without non invasive mechanical ventilation	2 h

Secondary Outcome Measures

Outcome Measure	Time Frame
Correlation between breathing swallowing interaction and functional respiratory parameters	24 h

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Investigators: Principal Investigator: Nicolas TERZI, MD - PhD, University Hospital, Caen; Principal Investigator: Frédéric Lofaso, MD-PhD, University Hospital, Garches

Publications and helpful links

General Publications

• Terzi N, Normand H, Dumanowski E, Ramakers M, Seguin A, Daubin C, Valette X, Masson R, Sauneuf B, Charbonneau P, du Cheyron D, Lofaso F. Noninvasive ventilation and breathing-swallowing interplay in chronic obstructive pulmonary disease*. Crit Care Med. 2014 Mar;42(3):565-73. doi: 10.1097/CCM.0b013e3182a66b4a.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: January 21, 2012
• First Submitted That Met QC Criteria: January 21, 2012
• First Posted (Estimated): January 25, 2012

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Intensive Care Unit; Chronic Obstructive Pulmonary Disease; Non invasive mechanical ventilation; Breathing-swallowing interaction
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive; Therapeutics; Airway Management; Respiratory Therapy; Respiration, Artificial; Noninvasive Ventilation
• Other Study ID Numbers: DEGLUT