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临床试验/NCT06552676
NCT06552676招募中不适用

Risk Factors for Neck Phlegmon After Percutaneous Tracheostomy in ICU

Azienda Usl di Bologna1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2018年8月9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
300
试验地点
1
主要终点
Neck phlegmon

研究概览

简要总结

Primary Purpose: To investigate the incidence and risk factors related to the appearance of tracheal phlegmon in patients undergoing percutaneous tracheostomy.

Participant Population/Primary Condition: Patients admitted to Intensive Care

Main Questions Aims to Answer:

    • What are the risk factors associated with the development of tracheal phlegmon percutaneous tracheostomy?
    • How does the appearance of tracheal phlegmon impact intensive care stay, hospital stay, mortality, and Health-related quality of life?

Participants will be followed up after undergoing tracheostomy for 7 days to identify eventual phlegmons.

At the two-year follow-up, the health-related quality of life will be assessed

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

  • Age greater than 18 years
  • Presence of indication for tracheostomy

排除标准

  • Failure of the percutaneous tracheostomy technique or recourse to surgical tracheostomy

结局指标

主要结局

Neck phlegmon

时间窗: 7 days

Neck phlegmon in the incisional site

次要结局

  • Intensive Care Stay(1 year)
  • Hospital Stay(1 year)
  • Mortality(30 days)
  • Cough(2 years)
  • Dysphonia(2 years)
  • Dyspnoea(2 years)
  • Health related quality of life(2 years)
  • Dysphagia(2 years)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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