Chronic Obstructive Pulmonary Disease (COPD)NCT01518075
Breathing-swallowing Interaction in Chronic Obstructive Pulmonary Disease Patients - Impact of Non Invasive Ventilation
A study testing Spontaneous Breathing and Non Invasive Mechanical Ventilation in people with Chronic Obstructive Pulmonary Disease (COPD) and Decompensated COPD With (Acute) Exacerbation, run by University Hospital, Caen at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD), Decompensated COPD With (Acute) Exacerbation
- What is being tested?
- Spontaneous Breathing and Non Invasive Mechanical Ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2012to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Hemodynamic instability
- Absence of consent
- Severe Hypoxemia
- pH < 7,30
- No cooperation of the patient
Trial locations and contacts
1 site in 1 country.
About this study
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
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)
Read the 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)
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD), Decompensated COPD With (Acute) Exacerbation
- Being tested
- Spontaneous Breathing, Non Invasive Mechanical Ventilation
- Keywords
- Chronic Obstructive Pulmonary Disease, Non invasive mechanical ventilation, Breathing-swallowing interaction, Intensive Care Unit
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spontaneous BreathingOther
Also called SB
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.
Non Invasive Mechanical VentilationOther
Also called NIV
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.
| Study group | Role | What they receive |
|---|---|---|
| Non invasive mechanical ventilation | Experimental | Evaluation of breathing swallowing interaction under non invasive mechanical ventilation Receives: Other: Non Invasive Mechanical Ventilation |
| Spontaneous Breathing | Active comparator | Evaluation of breathing swallowing interaction without non invasive mechanical ventilation Receives: Other: Spontaneous Breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of non invasive mechanical ventilation on breathing swallowing interaction
Physiological evaluation of breathing - swallowing interaction with or without non invasive mechanical ventilation
Measured: 2 h
Secondary outcomes (1)
Correlation between breathing swallowing interaction and functional respiratory parameters
Measured: 24 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas TERZI, MD - PhD, Principal investigator, University Hospital, CaenFrédéric Lofaso, MD-PhD, Principal investigator, University Hospital, Garches
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01518075
- Sponsor's protocol ID
- DEGLUT
- Status last verified
- Sep 2012
- First submitted
- 21 Jan 2012
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 24145847
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01518075
- Acronym / sponsor ID
- DEGLUT
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 25 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non invasive mechanical ventilation | Experimental | Other: Non Invasive Mechanical VentilationEvaluation of breathing swallowing interaction under non invasive mechanical ventilation |
| Spontaneous Breathing | Active comparator | Other: Spontaneous BreathingEvaluation of breathing swallowing interaction without non invasive mechanical ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- Hemodynamic instability
- Absence of consent
- Severe Hypoxemia
- pH < 7,30
- No cooperation of the patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spontaneous BreathingAlso: SBEvaluation 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 | Spontaneous Breathing |
| Non Invasive Mechanical VentilationAlso: NIVEvaluation 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 | Non invasive mechanical ventilation |
Primary outcome
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
1 secondary outcome
Correlation between breathing swallowing interaction and functional respiratory parameters
Time frame: 24 h
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Results publication: PubMed 24145847Terzi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas TERZI, MD - PhD principal investigator
University Hospital, Caen
Frédéric Lofaso, MD-PhD principal investigator
University Hospital, Garches
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spontaneous Breathing and Non Invasive Mechanical Ventilation in people with Chronic Obstructive Pulmonary Disease (COPD) and Decompensated COPD With (Acute) Exacerbation, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of non invasive mechanical ventilation on breathing swallowing interaction (time frame: 2 h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01518075, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.