Swallowing Rehabilitation of Dysphagic Tracheostomized Patients Under Mechanical Ventilation at ICU
NCT ID: NCT01496924
Last Updated: 2011-12-21
Study Results
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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UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2008-01-31
2012-06-30
Brief Summary
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Detailed Description
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The study consist of three stages: (1) sample selection with a test of the speaking valve and initial assessments, (2) swallowing rehabilitation and (3) post-treatment reassessments. Clinical assessments will be performed by speech-pathologists and otorhinolaryngologists with patients under mechanical ventilation. Subsequently, patients with dysphagia will be submitted to a rehabilitation program with standardized intervention, followed by a new assessment of abnormalities. The efficacy of swallowing treatment will be assessed by comparing the scores before and after treatment. Paired Student's test or Wilcoxon-test will be applied, according to data distribution. Categorical variables will be expressed as number and percentage and analyzed through McNemar test. All p-values will be two-sided and a p-value \< 0.05 considered statistically significant.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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speech therapy group
All dysphagic patients will be submitted to speech therapy
speech therapy
A single oral-motor technique will be used in a 10-times series intercalated with rest. Swallowing training techniques comprised indirect therapy (swallowing of saliva) and direct therapy (swallowing of food).
Interventions
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speech therapy
A single oral-motor technique will be used in a 10-times series intercalated with rest. Swallowing training techniques comprised indirect therapy (swallowing of saliva) and direct therapy (swallowing of food).
Eligibility Criteria
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Inclusion Criteria
* mechanical ventilation and tracheostomy for at least 48 hours
* appropriate level of consciousness (Glasgow coma scale ≥ 11)
* hemodynamic stability without need for vasoactive drugs
* minimum mechanical ventilation parameters characterized by pressure support ventilation (PSV) ≤ 20 cm H2O, positive end-expiratory pressure (PEEP) ≤ 8 cm H2O, fraction of inspired oxygen (FiO2) ≤ 50 and respiratory rate ≤ 30 inspirations per minute.
Exclusion Criteria
* nasal fracture or skull base fracture preventing otorhinolaryngological exam
* possible surgical treatment after ICU admission with no reasonable time for carrying out the planned intervention
* degenerative diseases characterized by outbreaks and remissions
* past history of oropharyngeal dysphagia
* previous speech therapy
* excessive amount of thick tracheal secretion requiring frequent tracheal suctioning
* end-stage of chronic obstructive pulmonary disease
* tracheoesophageal fistula
* allergy to dyes
* low survival expectancy.
18 Years
ALL
No
Sponsors
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Federal University of São Paulo
OTHER
Responsible Party
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Katia Alonso Rodrigues
principal investigator
Principal Investigators
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Katia Alonso, PHD
Role: PRINCIPAL_INVESTIGATOR
Federal University of São Paulo
Locations
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Intensive Care Unit - Hospital Sao Paulo
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Maria Inez Goncalves, PHD
Role: CONTACT
Phone: 55 11 55497500
Facility Contacts
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Katia Alonso, PHD
Role: primary
Other Identifiers
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CEP1802/06
Identifier Type: -
Identifier Source: org_study_id