Swallowing Rehabilitation of Dysphagic Tracheostomized Patients Under Mechanical Ventilation at ICU

Dysphagia Clinical Trial

Official title:

Swallowing Rehabilitation of Dysphagic Tracheostomized Patients Under Mechanical Ventilation at Intensive Care Unit

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01496924
• Other study ID #: CEP1802/06
• Status: Recruiting
• Phase: Phase 2
• First received: November 21, 2011
• Last updated: December 19, 2011
• Start date: January 2008
• Est. completion date: June 2012

Study information

• Verified date: December 2011
• Source: Federal University of São Paulo
• Contact: Katia Alonso, PHD
• Phone: 55 11 92119858
• Email: katiaalonso[@]terra.com.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dysphagia

Intervention

Other:
• 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).

Locations

Country	Name	City	State
Brazil	Intensive Care Unit - Hospital Sao Paulo	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	participants will be followed for the duration of ICU stay, an expected average of 2 weeks"	No