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Swallowing Disorders After Prolonged Mechanical Ventilation (Deglutube)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01360580
Recruitment Status : Completed
First Posted : May 25, 2011
Last Update Posted : January 24, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
Epidemiology study for evaluation of incidence of swallowing disorders (SD) after prolonged invasive ventilation (more than seven days), using a clinical statement. All consecutive patients are screened, and clinical evaluation is performed during 48h after patient's extubation. If a SD exist, a new evaluation is realized 48h after. Three groups will be created (1.no SD, 2.transitory SD and 3.persistent SD (eg persistent after 48h)). Data complementary are notified at day 28 (pneumonia? nutritional status?)

Condition or disease
Larynx Disease

Study Design

Study Type : Observational
Actual Enrollment : 138 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Current Care Study of Incidence and Consequences of Swallowing Disorders After Invasive Mechanical Ventilation
Study Start Date : January 2011
Primary Completion Date : February 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Prevalence of swallowing disorders after prolonged invasive ventilation [ Time Frame: 48 hours after extubation ]

Secondary Outcome Measures :
  1. Nutritional status at day 28 [ Time Frame: day 28 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
More than 7d of invasive mechanical ventilation

Inclusion Criteria:

  • More than 7 days of invasive mechanical ventilation

Exclusion Criteria:

  • Age < 18 years old
  • Preexistent swallowing disorders, stroke, tracheostomy
  • Failure of patient's agreement
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01360580

Service de Réanimation Médicale
Angers, France, 49933
service de Réanimation médicale
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
Principal Investigator: Gaetan Beduneau, Doctor Service de Réanimation médicale Hôpitaux de Rouen
More Information

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01360580     History of Changes
Other Study ID Numbers: 2009/110/HP
2008-A00057-50 ( Other Identifier: Id RCB )
First Posted: May 25, 2011    Key Record Dates
Last Update Posted: January 24, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Deglutition Disorders
Laryngeal Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Respiratory Tract Diseases