Status:
UNKNOWN
Swallowing Rehabilitation of Dysphagic Tracheostomized Patients Under Mechanical Ventilation at ICU
Lead Sponsor:
Federal University of São Paulo
Conditions:
Dysphagia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
There is an association between increased risk of oropharyngeal dysphagia and artificial ventilation through endotracheal tube, followed by tracheostomy. The aim of the present study is to analyze the...
Detailed Description
This prospective study will be conduct in seven intensive care units of the university public hospital Inclusion criteria are: patients under mechanical ventilation and tracheostomy for at least 48 ho...
Eligibility Criteria
Inclusion
- admission in an ICU
- 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
- surgery with resection of structures of oral cavity, pharynx, larynx and/or esophagus
- 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.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01496924
Start Date
January 1 2008
End Date
June 1 2012
Last Update
December 21 2011
Active Locations (1)
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1
Intensive Care Unit - Hospital Sao Paulo
São Paulo, São Paulo, Brazil, 04024900