Swallowing Rehabilitation of Dysphagic Tracheostomized Patients Under Mechanical Ventilation at ICU
Primary Purpose
Dysphagia
Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
speech therapy
Sponsored by
About this trial
This is an interventional treatment trial for Dysphagia focused on measuring Dysphagia, Intensive care units, Deglutition disorders, Rehabilitation
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.
Sites / Locations
- Intensive Care Unit - Hospital Sao PauloRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
speech therapy group
Arm Description
All dysphagic patients will be submitted to speech therapy
Outcomes
Primary Outcome Measures
dysphagia improvement
Otorhinolaryngological assessment will be carried out before and after treatment by means of a bedside video nasal endoscopic examination of swallowing, and included the evaluation of the following aspects: mobility of vocal folds, saliva and food swallowing, swallowing trigger time, food stasis in pharyngeal recesses, laryngeal penetration, tracheal aspiration, pharyngeal clearance after swallowing, laryngeal sensitivity and cough reflex, both by the speech-language pathologist and the otorrhinolaryngologist
Secondary Outcome Measures
Full Information
NCT ID
NCT01496924
First Posted
November 21, 2011
Last Updated
December 19, 2011
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01496924
Brief Title
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
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
June 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia
Keywords
Dysphagia, Intensive care units, Deglutition disorders, Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
speech therapy group
Arm Type
Other
Arm Description
All dysphagic patients will be submitted to speech therapy
Intervention Type
Other
Intervention Name(s)
speech therapy
Intervention Description
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).
Primary Outcome Measure Information:
Title
dysphagia improvement
Description
Otorhinolaryngological assessment will be carried out before and after treatment by means of a bedside video nasal endoscopic examination of swallowing, and included the evaluation of the following aspects: mobility of vocal folds, saliva and food swallowing, swallowing trigger time, food stasis in pharyngeal recesses, laryngeal penetration, tracheal aspiration, pharyngeal clearance after swallowing, laryngeal sensitivity and cough reflex, both by the speech-language pathologist and the otorrhinolaryngologist
Time Frame
participants will be followed for the duration of ICU stay, an expected average of 2 weeks"
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katia Alonso, PHD
Phone
55 11 92119858
Email
katiaalonso@terra.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Inez Goncalves, PHD
Phone
55 11 55497500
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katia Alonso, PHD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Intensive Care Unit - Hospital Sao Paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04024900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katia Alonso, PHD
Phone
55 11 92119858
First Name & Middle Initial & Last Name & Degree
Katia Alonso, PHD
12. IPD Sharing Statement
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Swallowing Rehabilitation of Dysphagic Tracheostomized Patients Under Mechanical Ventilation at ICU
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