Clinical Evaluation of Swallowing Disorders as a Predictor of Extubation Failure - Full Text View

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00780078

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

MedlinePlus related topics: Heart Failure Neurologic Diseases Poisoning Swallowing Disorders

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, 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

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

Rate of reintubation within the 72 hours after extubation [ Time Frame: 72 hours after extubation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00780078

Contacts

Contact: Alain YELNIK, MD

33 1 40 05 42 05

alain.yelnik@lrb.aphp.fr

Locations

France
Hôpital LARIBOISIERE	Recruiting
Paris, France, 75010
Contact: BAUD Frédéric, MDPhD 33 1 40 05 80 31 frederic.baud@lrb.aphp.fr

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

Alain YELNIK, MD

Assistance Publique - Hôpitaux de Paris

More Information

Responsible Party:	Department of clinical research and development ( Myriem CARRIER )
Study ID Numbers:	SCR060013, IRB00006477
Study First Received:	October 24, 2008
Last Updated:	December 1, 2008
ClinicalTrials.gov Identifier:	NCT00780078
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

Study placed in the following topic categories:

Heart Failure
Otorhinolaryngologic Diseases
Heart Diseases
Esophageal disorder
Gastrointestinal Diseases
Respiration Disorders
Respiratory Distress Syndrome, Adult
Poisoning
Disorders of Environmental Origin
Central Nervous System Diseases

Pharyngeal Diseases
Deglutition Disorders
Respiratory Insufficiency
Digestive System Diseases
Respiratory Tract Diseases
Shock
Lung Diseases
Acute respiratory distress syndrome
Esophageal Diseases

Additional relevant MeSH terms:

Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009