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临床试验/NCT05637944
NCT05637944招募中不适用

ThoRAciC Trauma IntubatiON Risk Score for Blunt Trauma

Azienda Usl di Bologna1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2022年10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
1,000
试验地点
1
主要终点
needing for oro-tracheal intubation within day 7th from admission

研究概览

简要总结

The primary objective of this study is the evaluation of risk factors associated with orotracheal intubation in blunt chest trauma patients not intubated on the field and not fulfilling the criteria for intubation based on the Glasgow Coma scale score with the building of a predictive score based on those findings taking into account the clinical, laboratory and radiologic tests performed within 6 hours from hospital admission.

详细描述

Multicentre, prospective, observational study. All the consecutive blunt thoracic trauma patients consecutively admitted at the participating institutions' Emergency Department (ED) will be considered for enrolment. The primary outcome measure will be the need for orotracheal intubation for primary respiratory failure lasting at least 48 hours within 7 days after trauma. The secondary outcome measures related to analgesia are: the basal analgesia protocol received during the first 7 days from ED admission and the median cumulative dose of morphine-equivalents received as rescue therapy during the first 7 days after trauma. The secondary outcome measure related to the sonographic evolution of thoracic lesions is the global and regional LUS.

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

  • Blunt thoracic trauma with a documentable lesion (T-AIS ≥ 2)
  • Age ≥ 18 years
  • GCS > 8 at ED admission
  • Total body CT scan available performed within 6 hours from ED admission

排除标准

  • - Penetrating thoracic trauma
  • Age < 18 years
  • GCS <= 8 at ED admission
  • Patients already intubated at ED arrival
  • Do not intubate order, for any reason
  • Intubation for Urgent/Emergent surgery within 24 hours from hospital arrival

结局指标

主要结局

needing for oro-tracheal intubation within day 7th from admission

时间窗: 7 days

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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