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临床试验/NCT02363686
NCT02363686已完成不适用

Aspiration in Acute Respiratory Failure Survivors

University of Colorado, Denver5 个研究点 分布在 1 个国家目标入组 248 人开始时间: 2012年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
248
试验地点
5
主要终点
Percentage of Participants Experiencing Aspiration

研究概览

简要总结

The purpose of this study is to learn more about problems with swallowing that could develop in patients who are very sick and need a machine to help them breathe.

详细描述

The purpose of this study is to learn more about problems with swallowing that could develop in patients who are very sick and need a machine to help them breathe. Patients are asked to be in this study because they had problems breathing on their own and therefore needed the help of a machine called a ventilator. In order for this ventilator to push air into the lungs, patients need a tube placed in the throat called an endotracheal tube. The process of placing this endotracheal tube was called intubation. The tube has now been removed, which is a process called extubation. Sometimes, people who have had endotracheal tubes can have difficulty swallowing food and liquids for a period of time. This disease is called post-extubation dysphagia (PED). PED is a serious condition and may result in food or liquid going from the mouth into the lungs. This could cause further lung problems. Given this risk, doctors sometimes suggest that patients with PED either avoid eating or drinking, or get a feeding tube. Currently, nobody knows how often patients develop PED, why they develop it, or the best method to detect it. Standard care involves clinicians making educated guesses. This study looks to determine if watching the patient swallow, both with and without a small camera, is an accurate method for detecting PED.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

  • Subjects will be eligible to participate in the study if they meet all of the following criteria:
  • Admission to a University of Colorado Hospital ICU
  • Mechanical ventilation support through an endotracheal tube for greater than 24 hours

排除标准

  • Subjects will be ineligible to participate in the study if they meet any of the following criteria
  • Age less than 18 years
  • Contraindication to enteral nutrition administration
  • Diagnosis of an acute or pre-existing central nervous system disorder (excluding a seizure disorder)
  • Pre-existing dysphagia
  • Previous surgery of the head, neck, or esophagus
  • Previous cancer of the head or neck
  • The presence of a tracheostomy
  • The presence of nasal or pharyngeal trauma or bleeding
  • Clinical team believes one of the protocols would be harmful to an individual patient
  • Expected survival less than 3 months
  • Imprisoned at the time of admission, anytime during the hospitalization, or anytime during the followup period
  • Inability to give informed consent and proxy unavailable.

结局指标

主要结局

Percentage of Participants Experiencing Aspiration

时间窗: from extubation Day 1 through hospital discharge, expected to be within 28 days

Aim: To develop a BSE-based non-invasive clinical prediction rule (CPR) that will accurately and efficiently diagnose aspiration in ARF survivors. Aspiration (PAS score of ≥6) on the FEES with any of the five feedings. This outcome measure will report the percentage of participants experiencing silent and non-silent aspiration, as visualized on the FEES. The FEES is a flexible fiberoptic camera that allows the investigators to visualize the patient swallowing each of the 5 different consistencies of food.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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