跳至主要内容
临床试验/NCT05922085
NCT05922085招募中不适用

Use of Ultrasound for Early Identification of Patients at Risk of Swallowing Disorders Acquired in the ICU

Centre Hospitalier Universitaire Dijon2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年11月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
rate of swallowing disorders

研究概览

简要总结

Swallowing disorders (SD) are particularly common after extubation in the ICU and may be associated with an increased risk of lung disease, increased length of hospital stay, and a higher risk of early reintubation. In contrast, early detection of SDs has been shown to be associated with a decrease in these complications. Thus, there is a need for rapid and reliable assessment of SDs in ICU patients before the withdrawal of mechanical ventilation.

Videofluoroscopy (VFS) and nasofibroscopy (NF) are the gold standard examinations for diagnosing SD. However, these two examinations are not feasible in intubated patients.

In this context, ultrasound appears to be a promising alternative to identify patients at risk of SD after extubation. This examination can be performed at the intubated patient's bedside and can be used evaluate the mobility of the structures involved in swallowing. Many studies have already shown the interest of ultrasound in the evaluation of SD but none has focused on intubated patients under respiratory assistance.

The objective of the present study is to evaluate the value of ultrasound in identifying patients at risk of presenting SD after extubation.

This monocentric study will take place in the Intensive Care Unit (ICU) of the Dijon University Hospital. The duration of participation in this research will be equal to the length of stay in the ICU. During their stay, patients will undergo ultrasound and nasofibroscopy. Information on the characteristics of the ICU stay will be collected at discharge.

研究设计

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

  • Major (≥18)
  • On mechanical ventilation for at least 48 hours
  • Affiliated to national health insurance

排除标准

  • Under legal protection (curatorship, guardianship, safeguard of justice)
  • Pregnant, parturient or breastfeeding woman
  • Refusal to participate by the patient or their proxy (or an immediate family member)
  • Cognitive disorders incompatible with the understanding of instructions
  • Previously diagnosed swallowing disorders
  • With a neurological condition at the origin of the SD (stroke, ALS...)
  • Treated for a lesion of the aerodigestive tract (by surgery, radiotherapy or radio-chemotherapy)
  • presence of wounds or dressings on the areas to be evaluated that prevent ultrasound measurements
  • Patient for whom a decision to limit or stop life support treatments has been taken collegially within the intensive care unit
  • With one or more contraindications to performing NF:
  • Anatomical features not compatible with NF: mainly deviation of the nasal septum.
  • Risk of significant otorhinolaryngological bleeding

研究组 & 干预措施

patient under mechanical ventilation for at least 48 hours

Experimental

干预措施: Ultrasound (Other)

patient under mechanical ventilation for at least 48 hours

Experimental

干预措施: nasofibroscopie (Other)

结局指标

主要结局

rate of swallowing disorders

时间窗: Within 3 to 24 hours of extubation

assessed by the Penetration-Aspiration Scale (PAS)

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 (2)

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