Swallowing Rehabilitation of Dysphagic Tracheostomized Patients Under Mechanical Ventilation at ICU

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Federal University of São Paulo.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Katia Alonso Rodrigues, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01496924
First received: November 21, 2011
Last updated: December 19, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Dysphagia
Other: speech therapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Swallowing Rehabilitation of Dysphagic Tracheostomized Patients Under Mechanical Ventilation at Intensive Care Unit

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • dysphagia improvement [ Time Frame: participants will be followed for the duration of ICU stay, an expected average of 2 weeks" ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 30
Study Start Date: January 2008
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
speech therapy group
All dysphagic patients will be submitted to speech therapy
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).

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01496924

Contacts
Contact: Katia Alonso, PHD 55 11 92119858 katiaalonso@terra.com.br
Contact: Maria Inez Goncalves, PHD 55 11 55497500

Locations
Brazil
Intensive Care Unit - Hospital Sao Paulo Recruiting
Sao Paulo, SP, Brazil, 04024900
Contact: Katia Alonso, PHD    55 11 92119858      
Principal Investigator: Katia Alonso, PHD         
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Katia Alonso, PHD Federal University of São Paulo
  More Information

No publications provided

Responsible Party: Katia Alonso Rodrigues, principal investigator, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01496924     History of Changes
Other Study ID Numbers: CEP1802/06
Study First Received: November 21, 2011
Last Updated: December 19, 2011
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:
Dysphagia
Intensive care units
Deglutition disorders
Rehabilitation

Additional relevant MeSH terms:
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on July 24, 2014