- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01496924
Swallowing Rehabilitation of Dysphagic Tracheostomized Patients Under Mechanical Ventilation at ICU
Swallowing Rehabilitation of Dysphagic Tracheostomized Patients Under Mechanical Ventilation at Intensive Care Unit
Study Overview
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Katia Alonso, PHD
- Phone Number: 55 11 92119858
- Email: katiaalonso@terra.com.br
Study Contact Backup
- Name: Maria Inez Goncalves, PHD
- Phone Number: 55 11 55497500
Study Locations
-
-
SP
-
Sao Paulo, SP, Brazil, 04024900
- Recruiting
- Intensive Care Unit - Hospital Sao Paulo
-
Contact:
- Katia Alonso, PHD
- Phone Number: 55 11 92119858
-
Principal Investigator:
- Katia Alonso, PHD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: speech therapy group
All dysphagic patients will be submitted to 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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
dysphagia improvement
Time Frame: participants will be followed for the duration of ICU stay, an expected average of 2 weeks"
|
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
|
participants will be followed for the duration of ICU stay, an expected average of 2 weeks"
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Katia Alonso, PHD, Federal University of São Paulo
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEP1802/06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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