Clinical trial NCT01496924: Swallowing Rehabilitation of Dysphagic Tracheostomized Patients Under Mechanical Ventilation at ICU
Official title: Swallowing Rehabilitation of Dysphagic Tracheostomized Patients Under Mechanical Ventilation at Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Dysphagia
Keywords: Dysphagia
Intensive care units
Deglutition disorders
Rehabilitation
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2011-12-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: dysphagia improvement
timeFrame: participants will be followed for the duration of ICU stay, an expected average of 2 weeks"
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Intensive Care Unit - Hospital Sao Paulo
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: Katia Alonso, PHD
role: PRINCIPAL_INVESTIGATOR
References: