Swallowing Disorders After Prolonged Mechanical Ventilation (Deglutube)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01360580
First received: May 24, 2011
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

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
Larynx Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Current Care Study of Incidence and Consequences of Swallowing Disorders After Invasive Mechanical Ventilation

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • Prevalence of swallowing disorders after prolonged invasive ventilation [ Time Frame: 48 hours after extubation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Nutritional status at day 28 [ Time Frame: day 28 ] [ Designated as safety issue: Yes ]

Enrollment: 138
Study Start Date: January 2011
Study Completion Date: December 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

More than 7d of invasive mechanical ventilation

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01360580

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

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01360580     History of Changes
Other Study ID Numbers: 2009/110/HP, 2008-A00057-50
Study First Received: May 24, 2011
Last Updated: January 23, 2013
Health Authority: France: National Consultative Ethics Committee for Health and Life Sciences

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

ClinicalTrials.gov processed this record on July 31, 2014