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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00780078
Other study ID # SCR060013
Secondary ID IRB00006477
Status Completed
Phase N/A
First received October 24, 2008
Last updated January 3, 2017
Start date October 2008
Est. completion date September 2010

Study information

Verified date December 2016
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date September 2010
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Prospective


Intervention

Procedure:
extubation
extubation failure in patients intubated orotracheally

Locations

Country Name City State
France Hôpital LARIBOISIERE Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of reintubation within the 72 hours after extubation 72 hours after extubation No
Secondary Delay for reintubation (hours) 72 hours after extubation No
Secondary Number of daily pharyngeal or tracheal suctioning 72 hours after extubation No
Secondary Pulmonary infection 72 hours after extubation No
Secondary Mortality 7 days No
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