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临床试验/NCT01496924
NCT01496924Unknown2 期

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

Federal University of São Paulo2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2008年1月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
发起方
入组人数
30
试验地点
2
主要终点
dysphagia improvement

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

speech therapy group

Other

All dysphagic patients will be submitted to speech therapy

干预措施: speech therapy (Other)

结局指标

主要结局

dysphagia improvement

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Katia Alonso Rodrigues

principal investigator

Federal University of São Paulo

研究点 (2)

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