Clinical trial NCT00780078: Clinical Evaluation of Swallowing Disorders as a Predictor of Extubation Failure
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Central Nervous System Diseases
Acute Respiratory Failure
Shock
Heart Failure
Acute Poisoning
Keywords: Intensive care unit
Extubation failure
Physiotherapist
Pre-extubation bedside tests
Swallowing disorders
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2008-10-27
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

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 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

Primary outcomes:
measure: Rate of reintubation within the 72 hours after extubation
timeFrame: 72 hours after extubation
Secondary outcomes:
measure: Delay for reintubation (hours)
timeFrame: 72 hours after extubation
measure: Number of daily pharyngeal or tracheal suctioning
timeFrame: 72 hours after extubation
measure: Pulmonary infection
timeFrame: 72 hours after extubation
measure: Mortality
timeFrame: 7 days
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital LARIBOISIERE
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Alain YELNIK, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Houze MH, Deye N, Mateo J, Megarbane B, Bizouard F, Baud FJ, Payen de la Garanderie D, Vicaut E, Yelnik AP; EVAKIN Study Group. Predictors of Extubation Failure Related to Aspiration and/or Excessive Upper Airway Secretions. Respir Care. 2020 Apr;65(4):475-481. doi: 10.4187/respcare.07025. Epub 2019 Nov 19.