Clinical Evaluation of Swallowing Disorders as a Predictor of Extubation Failure (EVAKIN)
Recruitment status was Recruiting
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Purpose
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 | Intervention |
|---|---|
|
Central Nervous System Diseases Acute Respiratory Failure Shock Heart Failure Acute Poisoning |
Procedure: extubation |
| Study Type: | Observational |
| Study Design: | 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 |
- Rate of reintubation within the 72 hours after extubation [ Time Frame: 72 hours after extubation ] [ Designated as safety issue: No ]
- Delay for reintubation (hours) [ Time Frame: 72 hours after extubation ] [ Designated as safety issue: No ]
- Number of daily pharyngeal or tracheal suctioning [ Time Frame: 72 hours after extubation ] [ Designated as safety issue: No ]
- Pulmonary infection [ Time Frame: 72 hours after extubation ] [ Designated as safety issue: No ]
- Mortality [ Time Frame: 7 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 160 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | October 2010 |
| Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
Patients intubated orotracheally for over 6 days
|
Procedure: extubation
extubation failure in patients intubated orotracheally
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
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| Contact: Alain YELNIK, MD | 33 1 40 05 42 05 | alain.yelnik@lrb.aphp.fr |
| France | |
| Hôpital LARIBOISIERE | Recruiting |
| Paris, France, 75010 | |
| Contact: BAUD Frédéric, MDPhD 33 1 40 05 80 31 frederic.baud@lrb.aphp.fr | |
| Principal Investigator: | Alain YELNIK, MD | Assistance Publique - Hôpitaux de Paris |
More Information
No publications provided
| Responsible Party: | Myriem CARRIER, Department of clinical research and development |
| ClinicalTrials.gov Identifier: | NCT00780078 History of Changes |
| Other Study ID Numbers: | SCR060013, IRB00006477 |
| Study First Received: | October 24, 2008 |
| Last Updated: | December 1, 2008 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Intensive care unit Extubation failure Physiotherapist Pre-extubation bedside tests Swallowing disorders |
Additional relevant MeSH terms:
|
Central Nervous System Diseases Deglutition Disorders Heart Failure Nervous System Diseases Poisoning Shock Respiratory Distress Syndrome, Adult Respiratory Insufficiency Esophageal Diseases Gastrointestinal Diseases |
Digestive System Diseases Pharyngeal Diseases Otorhinolaryngologic Diseases Heart Diseases Cardiovascular Diseases Substance-Related Disorders Pathologic Processes Lung Diseases Respiratory Tract Diseases Respiration Disorders |
ClinicalTrials.gov processed this record on May 22, 2013