Swallowing Disorders After Prolonged Mechanical Ventilation (Deglutube)

January 23, 2013 updated by: University Hospital, Rouen

Current Care Study of Incidence and Consequences of Swallowing Disorders After Invasive Mechanical Ventilation

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?)

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

138

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • Service de Réanimation Médicale
      • Rouen, France, 76031
        • Service de Réanimation Médicale

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

More than 7d of invasive mechanical ventilation

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of swallowing disorders after prolonged invasive ventilation
Time Frame: 48 hours after extubation
48 hours after extubation

Secondary Outcome Measures

Outcome Measure
Time Frame
Nutritional status at day 28
Time Frame: day 28
day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Investigators

  • Principal Investigator: Gaetan Beduneau, Doctor, Service de Réanimation médicale Hôpitaux de Rouen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

May 24, 2011

First Submitted That Met QC Criteria

May 24, 2011

First Posted (Estimate)

May 25, 2011

Study Record Updates

Last Update Posted (Estimate)

January 24, 2013

Last Update Submitted That Met QC Criteria

January 23, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009/110/HP
  • 2008-A00057-50 (Other Identifier: Id RCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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