Clinical Evaluation of Swallowing Disorders as a Predictor of Extubation Failure

Heart Failure Clinical Trial

— EVAKIN  

Official title:

Clinical Evaluation by Physical Therapist of Swallowing Disorders as a Predictor of Extubation Failure in Patients Intubated Orotracheally for Over 6 Days

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

Related Conditions & MeSH terms

• Acute Poisoning
• Acute Respiratory Failure
• Central Nervous System Diseases
• Deglutition Disorders
• Heart Failure
• Nervous System Diseases
• Poisoning
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency
• Shock

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