Swallowing Rehabilitation of Dysphagic Tracheostomized Patients Under Mechanical Ventilation at ICU

December 19, 2011 updated by: Katia Alonso Rodrigues, Federal University of São Paulo

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Katia Alonso, PHD, Federal University of São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (ANTICIPATED)

January 1, 2012

Study Completion (ANTICIPATED)

June 1, 2012

Study Registration Dates

First Submitted

November 21, 2011

First Submitted That Met QC Criteria

December 19, 2011

First Posted (ESTIMATE)

December 21, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

December 21, 2011

Last Update Submitted That Met QC Criteria

December 19, 2011

Last Verified

December 1, 2011

More Information

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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