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Clinical Evaluation of Swallowing Disorders as a Predictor of Extubation Failure (EVAKIN)

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: NCT00780078
Recruitment Status : Completed
First Posted : October 27, 2008
Last Update Posted : January 4, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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Brief Summary:
Patients with failed extubation stay significantly longer in an intensive care unit (ICU) and have a higher mortality rate, than those intubated successfully. Reintubation is associated with life-threatening complications and a poor prognosis. Functional respiratory tests are frequently used as weaning parameters, however, they are not accurate enough to predict extubation failure. The incidence of swallowing dysfunction is underestimated, mainly among patients whose intubation lasts longer than 48 h.We previously observed that the assessment of the swallowing function and oropharyngeal motricity, conducted by the physiotherapist before extubation could be helpful for making decisions to extubate patients intubated for over 6 days. The objective of this study is to validate a scale previously devised and used for physiotherapist bedside evaluation of the swallowing function and oropharyngeal motricity, among patients intubated for over 6 days, to determine whether this scale is a good predictor of airway secretion-related extubation failure.Expected results : to validate a scale previously devised called " physiotherapist evaluation of the swallowing function and oropharyngeal motricity before extubation" by the mean of a multicentric study. In our hypothesis the clinical parameters studied could be predictive of extubation failure. Then, this evaluation could help the medical decision in the choice of the good time for extubation. The final objective is to lower the mortality related to extubation failure.

Condition or disease Intervention/treatment
Central Nervous System Diseases Acute Respiratory Failure Shock Heart Failure Acute Poisoning Procedure: extubation

Detailed Description:
  • Patients selection, inclusion and procedure: All successive patients admitted to the medical or surgical ICU, and intubated by the orotracheal route for >6 days, will be prospectively enrolled when extubation will be decided. Patients with previous swallowing disorders, ENT surgery or chronic persistent vegetative status will not be included. All patients will have to fulfill the usual criteria for extubation. Then, before extubation, the different components of swallowing functions will be evaluated by the trained physiotherapist, using a bedside pre-extubation scale based on 3 tests: assessment of 1)- cervical, oral, labial and lingual motricity; 2)- the gag reflex; and 3)- swallowing. After extubation, the ability to cough and swallow, secretion volume, and the need for suctioning will be evaluated immediately, then at 24, 48 and 72 hours.
  • Expected results : to validate a scale previously devised called " physiotherapist evaluation of the swallowing function and oropharyngeal motricity before extubation" by the mean of a multicentric study. In our hypothesis the clinical parameters studied could be predictive of extubation failure. Then, this evaluation could help the medical decision in the choice of the good time for extubation. The final objective is to lower the mortality related to extubation failure.
Study Design
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Study Type : Observational
Actual Enrollment : 160 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Evaluation by Physical Therapist of Swallowing Disorders as a Predictor of Extubation Failure in Patients Intubated Orotracheally for Over 6 Days
Study Start Date : October 2008
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
1
Patients intubated orotracheally for over 6 days
 Procedure: extubation
extubation failure in patients intubated orotracheally


Outcome Measures
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Primary Outcome Measures :
  1. Rate of reintubation within the 72 hours after extubation [ Time Frame: 72 hours after extubation ]

Secondary Outcome Measures :
  1. Delay for reintubation (hours) [ Time Frame: 72 hours after extubation ]
  2. Number of daily pharyngeal or tracheal suctioning [ Time Frame: 72 hours after extubation ]
  3. Pulmonary infection [ Time Frame: 72 hours after extubation ]
  4. Mortality [ Time Frame: 7 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
the objective of this study is to validate a scale previously devised and used for physiotherapist bedside evaluation of the swallowing function and oropharyngal motricity, among patients intubated for over 6 days, to determine whether this scale is a good predictor of airway secretion-related extubation failure
Criteria

Inclusion Criteria:

  • age over 18 years
  • patients intubated orotracheally for over 6 days
  • patients fulfilling usual medical criteria for extubation, after a successful test of spontaneous ventilation, according to the French consensus conference (2001).

Exclusion Criteria:

  • post ENT surgery- previous swallowing disorders
  • chronic vegetative status
Contacts and Locations
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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): NCT00780078


Locations
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France
Hôpital LARIBOISIERE
Paris, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Alain YELNIK, MD Assistance Publique - Hôpitaux de Paris
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00780078    
Other Study ID Numbers: SCR060013
IRB00006477
First Posted: October 27, 2008    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: December 2016
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Intensive care unit
Extubation failure
Physiotherapist
Pre-extubation bedside tests
Swallowing disorders
Additional relevant MeSH terms:
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Deglutition Disorders
Respiratory Insufficiency
Nervous System Diseases
Central Nervous System Diseases
Poisoning
Respiration Disorders
Respiratory Tract Diseases
 Chemically-Induced Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases