Clinical Evaluation of Swallowing Disorders as a Predictor of Extubation Failure

NCT ID: NCT00780078

Last Updated: 2017-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-09-30

Brief Summary

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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

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* 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.

Conditions

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Central Nervous System Diseases Acute Respiratory Failure Shock Heart Failure Acute Poisoning

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Patients intubated orotracheally for over 6 days

extubation

Intervention Type PROCEDURE

extubation failure in patients intubated orotracheally

Interventions

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extubation

extubation failure in patients intubated orotracheally

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alain YELNIK, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Hôpital LARIBOISIERE

Paris, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 31744867 (View on PubMed)

Other Identifiers

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IRB00006477

Identifier Type: -

Identifier Source: secondary_id

SCR060013

Identifier Type: -

Identifier Source: org_study_id

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