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临床试验/NCT07123857
NCT07123857招募中不适用

Impact of Point-of-care Lactate Testing as Triage Supplement on Patient Management Using Manchester Triage System

University Medical Centre Maribor1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年7月10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
发起方
入组人数
200
试验地点
1
主要终点
Vasoactive drug use

研究概览

简要总结

Although the Manchester Triage System (MTS) is widely used and validated internationally, it has some limitations. Its accuracy is moderate, especially for children and the elderly. Rising patient numbers and overcrowded emergency departments increase wait times, sometimes beyond safe limits. In Slovenia, MTS has been in use for 14 years without major updates, despite a significant rise in emergency visits. The yellow triage category (60-minute wait time) includes a very diverse group of patients, some of whom might require faster care. Older patients, in particular, often show atypical symptoms and may be under-triaged. Including rapid bedside lab tests, like blood lactate levels, could improve risk assessment and triage accuracy. Elevated lactate is linked with higher mortality and can help identify critically ill patients more effectively. The proposed study is a prospective, randomized trial involving two groups of patients in the yellow triage category, all of whom will have their capillary blood lactate levels measured. Patients with normal lactate levels will be excluded. Only patients with elevated lactate will be compared. The test group will be re-triaged to the orange category and treated more urgently. The control group, despite also having high lactate levels, will remain in the yellow category, and their elevated lactate values will not be shared with the treating physician. Randomization will be based on the patient's birth date (even days = test group, odd days = control group). Only the nurse will know the result, maintaining physician blinding to avoid the Hawthorne effect-changes in behavior due to awareness of being studied. Standard lab tests will be performed later during treatment as deemed necessary by the attending doctor.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •signed consent, yellow MTS triage category

排除标准

  • •pregnant women, trauma patients, epileptic seizures, adrenergic therapy in prehospital unit

研究组 & 干预措施

Control group - No-retriage

No Intervention

Test group - Retriage to orange MTS group

Experimental

干预措施: re-triage (Diagnostic Test)

结局指标

主要结局

Vasoactive drug use

时间窗: 30-day

次要结局

  • In-hospital mortality(30-day)
  • ICU admission(30-day)

研究者

发起方
University Medical Centre Maribor
申办方类型
Other
责任方
Sponsor

研究点 (1)

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