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临床试验/NCT04428749
NCT04428749Unknown不适用

Swallowing Difficulties in ICU Patients [Synkebesvær Hos Intensivpatienter]

Hospitalsenheden Vest1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
35
试验地点
1
主要终点
Aspiration on FEES

研究概览

简要总结

Swallow disorders or dysphagia related to mechanical ventilation affects between 1,300 and 2,000 patients in Danish intensive care units every year and increases aspiration, pneumonia and risk of dying. In intensive care units, dysphagia may vary around the clock as fatigue and fluctuating alertness play an important role for the patients' ability to swallow effectively without aspiration to the airway. For this reason, ICU nurses must be able to assess dysphagia in the ICU patient day and night, but guidelines are lacking.

One of the simplest and most sensitive methods is the Yale Swallow Protocol, however, this protocol requires translation and validation before it can be implemented in Danish intensive care units. This project aims to translate and validate the Yale Swallow Protocol for use in Danish intensive care units. Furthermore, this project will explore nurses' perceptions and management of dysphagia in the intensive care unit as well as feasibility and acceptability of the Yale Swallow Protocol.

详细描述

Introduction Dysphagia caused by intubation and mechanical ventilation affects between 1.300 - 2.000 patients in Danish intensive care units (ICU's) every year. Dysphagia increases the risk of aspiration, pneumonia, repeated mechanical ventilation and mortality. Despite this, national and international guidelines for treating dysphagia in the ICU are lacking. In ICU patients, dysphagia may vary around the clock as fatigue and cerebral status plays an important role for the patients' ability to swallow effectively without aspiration. For this reason, ICU nurses must be able to assess dysphagia in the ICU patient day and night. This will be an important addition to assessments made by occupational therapists usually only available in the morning hours. However, for nurses to be able to assess dysphagia in the ICU patients; development and validation of screening procedures are highly needed.

The development of a validated screening procedure to detect dysphagia in ICU patients will furthermore pave the way for the developing and testing nursing interventions aiming at improving dysphagia in ICU patients. This may reduce complications and improve quality of life in patients.

Dysphagia related to mechanical ventilation and intensive care The swallow function depends on a complicated interplay between more than 30 muscle pairs, cranial nerves and areas in the cortex and the medulla oblongata. Causes for dysphagia in ICU patients are only partially understood, however, the following factors have been suggested as significant: 1) Trauma to the pharynx caused by intubation (placing a tube for mechanical ventilation in the airway), 2) Neuromyopathy resulting in muscular weakness, 3) Decreased level of consciousness caused by medication, delirium or critical illness. Moreover, these factors may cause dysphagia in ICU patients to vary from day to night.

Dysphagia is a serious complication to critical illness, potentially increasing mortality. Despite this, research shows that nursing practice varies greatly. Nurses have different views on what constitutes safe swallowing. Nonetheless, it often falls upon nurses to assess patients swallowing function and determine whether to offer the patient something to eat and drink or not. Thus, developing valid screening methods that can be used by ICU nurses may improve patient safety and reduce complications due to dysphagia caused by intubation, mechanical ventilation and critical illness.

Diagnosing dysphagia using FEES Dysphagia can be diagnosed using instrumental methods such as the fiberoptic endoscopic evaluation of swallowing (FEES). This method is considered a gold standard in assessing dysphagia. FEES may be performed bed-side by physicians or occupational therapists by testing different foods and consistencies, but some patients find the FEES disagreeable. A clinical examination by occupational therapists is another way to diagnose dysphagia, however, silent aspiration without choking or coughing is difficult to detect in a clinical examination.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Aspiration on FEES

时间窗: Within 24 hours of extubation

Penetration aspiration scale (PAS scale) equal to or larger than 6

Yale Swallow protocol

时间窗: Within 30 minutes of the FEES

Passed or not passed

次要结局

  • Mortality(30 days after extubation)

研究者

发起方
Hospitalsenheden Vest
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anne Højager Nielsen

Principal Investigator, MCN, PH.D.

Hospitalsenheden Vest

研究点 (1)

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