- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00780078
Clinical Evaluation of Swallowing Disorders as a Predictor of Extubation Failure (EVAKIN)
January 3, 2017 updated by: Assistance Publique - Hôpitaux de Paris
Clinical Evaluation by Physical Therapist of Swallowing Disorders as a Predictor of Extubation Failure in Patients Intubated Orotracheally for Over 6 Days
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
160
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
-
-
-
Paris, France, 75010
- Hôpital Lariboisière
-
-
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
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
Description
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
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1
Patients intubated orotracheally for over 6 days
|
extubation failure in patients intubated orotracheally
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of reintubation within the 72 hours after extubation
Time Frame: 72 hours after extubation
|
72 hours after extubation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mortality
Time Frame: 7 days
|
7 days
|
Delay for reintubation (hours)
Time Frame: 72 hours after extubation
|
72 hours after extubation
|
Number of daily pharyngeal or tracheal suctioning
Time Frame: 72 hours after extubation
|
72 hours after extubation
|
Pulmonary infection
Time Frame: 72 hours after extubation
|
72 hours after extubation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Alain YELNIK, MD, Assistance Publique - Hôpitaux de Paris
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.
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
October 1, 2008
Primary Completion (ACTUAL)
September 1, 2010
Study Completion (ACTUAL)
September 1, 2010
Study Registration Dates
First Submitted
October 24, 2008
First Submitted That Met QC Criteria
October 24, 2008
First Posted (ESTIMATE)
October 27, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
January 4, 2017
Last Update Submitted That Met QC Criteria
January 3, 2017
Last Verified
December 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Chemically-Induced Disorders
- Digestive System Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Gastrointestinal Diseases
- Pharyngeal Diseases
- Otorhinolaryngologic Diseases
- Esophageal Diseases
- Poisoning
- Respiratory Insufficiency
- Nervous System Diseases
- Deglutition Disorders
- Central Nervous System Diseases
Other Study ID Numbers
- SCR060013
- IRB00006477
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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