Swallowing Rehabilitation of Dysphagic Tracheostomized Patients Under Mechanical Ventilation at ICU

Federal University of São Paulo

Status and phase

Unknown

Phase 2

Conditions

Dysphagia

Treatments

Other: speech therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01496924

CEP1802/06

Details and patient eligibility

About

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 outcomes of an early swallowing rehabilitation program of dysphagic tracheostomized patients under mechanical ventilation at the intensive care unit.

Full 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 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. Primary exclusion criteria are: patients who underwent 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, and low survival expectancy.

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.