跳至主要内容
临床试验/NCT05611437
NCT05611437招募中不适用

Ultrafast Ultrasonographic Oro-laryngeal Measurement in Critically Ill Patients During Weaning From Mechanical Ventilation

Groupe Hospitalier du Havre1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
1
主要终点
Correlation between laryngeal ultrafast ultrasonography and occurence of laryngeal edema

研究概览

简要总结

In ICU, ventilatory weaning failure is common, accounting for up to 25% of extubations. These failures are largely due to swallowing disorders and laryngeal edema. Edema prevalence in ICU varies between 4 and 37%.

Post-extubation stridor is a clinical sign of upper airway obstruction and may require urgent reintubation, which is associated with increased patient length of stay, morbidity and mortality.

Identifying patients at risk is critical, and the need for reliable tools to predict the occurence of laryngeal edema is still relevant.

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

  • Intubated and ventilated for more than 24h,
  • Filing mechanical ventilation weaning criteria.

排除标准

  • Pregnant of breast-feeding woman,
  • Under guardianship patient,
  • History of laryngeal tumor, stroke, paralysis of recurrent nerve, swallowing disorders,
  • History of surgical laryngeal intervention or radiotherapy,
  • Unplanned extubation,
  • Opposition to take part in the study.

结局指标

主要结局

Correlation between laryngeal ultrafast ultrasonography and occurence of laryngeal edema

时间窗: Within the 24 hours following extubation

A laryngeal edema is defined as a post-extubation stridor. Performance of ultrafast ultrasonography for laryngeal edema prediction in intensive care patients will be assessed with specificity, sensitivity, positive predictive value and negative predictive value.

次要结局

  • Correlation between laryngeal ultrafast ultrasonography and occurence of swallowing disorders(Within the 24 hours following extubation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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