NCT01518075

Brief 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 exacerbation, and evaluate the impact of using non invasive mechanical ventilation (NIV)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 25, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

April 2, 2026

Status Verified

September 1, 2012

Enrollment Period

7 months

First QC Date

January 21, 2012

Last Update Submit

March 30, 2026

Conditions

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

Keywords

Chronic Obstructive Pulmonary DiseaseNon invasive mechanical ventilationBreathing-swallowing interactionIntensive Care Unit

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Correlation between breathing swallowing interaction and functional respiratory parameters

    24 h

Study Arms (2)

Non invasive mechanical ventilation

EXPERIMENTAL

Evaluation of breathing swallowing interaction under non invasive mechanical ventilation

Other: Non Invasive Mechanical Ventilation

Spontaneous Breathing

ACTIVE COMPARATOR

Evaluation of breathing swallowing interaction without non invasive mechanical ventilation

Other: Spontaneous Breathing

Interventions

Spontaneous BreathingOTHER

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.

Also known as: SB
Spontaneous Breathing
Non Invasive Mechanical VentilationOTHER

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.

Also known as: NIV
Non invasive mechanical ventilation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Hemodynamic instability
  • Absence of consent
  • Severe Hypoxemia
  • pH \< 7,30
  • No cooperation of the patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Caen

Caen, 14000, France

Location

Related Publications (1)

  • 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.

    PMID: 24145847RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Nicolas TERZI, MD - PhD

    University Hospital, Caen

    PRINCIPAL INVESTIGATOR

  • Frédéric Lofaso, MD-PhD

    University Hospital, Garches

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2012

First Posted

January 25, 2012

Study Start

January 1, 2012

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

April 2, 2026

Record last verified: 2012-09

Locations

FR(1)