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临床试验/NCT03980613
NCT03980613已完成不适用

The Initial Presentation of Patients With Spontaneous Subarachnoid Haemorrhage During Emergency Telephone Calls

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 892 人开始时间: 2019年8月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
892
试验地点
1
主要终点
Proportions of patients with each symptom

研究概览

简要总结

It is the primary aim of this study to identify symptoms and/or specific words (trigger words) indicative of spontaneous subarachnoid haemorrhage (sSAH) during emergency telephone calls to the Emergency Medical Service Copenhagen (EMS).

Further, it is the aim to determine the association between the symptoms/trigger words and sSAH, the sensitivity of the symptoms/trigger words and finally, to identify factors in the telephone visitation that may influence the level of activated prehospital response

详细描述

Study design: Nested case-control study.

Data sources:

A cohort of patients with confirmed sSAH is established. It will consist of patients admitted between January 1, 2014 and December 31, 2018 registered in the Danish National Patient Register with a primary discharge diagnosis of spontaneous subarachnoid haemorrhage (International Classification of Disease code I60.0-I60.9). Using central person register-numbers, their medical records will be extracted and reviewed to validate the diagnosis. Validation is performed by two independent investigators with the assistance of a predeveloped case report form with diagnostic criteria (named "CRF Diagnosis validation"). At the time of the study design, the cohort contains data on patients from year 2014 from a previous study. For the present study data must be collected on patients from year 2015 to 2018. The Danish National Patient Register is accessed online via the Danish Health Data Board (Sundhedsdatastyrelsen).

Controls are identified in the EMS Copenhagen database of emergency telephone calls.

Audiotaped emergency medical telephone calls are kept on record at the EMS Copenhagen. Audio files of calls from patients with confirmed sSAH and selected controls are extracted.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

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

  • Having called the emergency medical service Copenhagen between January 1, 2014 and December 31,
  • Must have a Danish Central Person Register-number.
  • Cases must be first-ever subarachnoid haemorrhages.
  • Cases must have survived to admission.

排除标准

  • Patients transferred to a to a hospital in the Capital Region of Denmark from abroad or from another Danish geopolitical region.
  • Subarachnoid haemorrhages that have occurred during hospitalization are also excluded.

结局指标

主要结局

Proportions of patients with each symptom

时间窗: Day 0

The proportions of patients presenting with each identified symptom and/or trigger word described during emergency telephone calls, among patients with first-ever sSAH.

次要结局

  • Odds ratios for having sSAH for each symptom identified under the primary outcome.(Day 0)
  • Sensitivity of each symptom.(Day 0)
  • Emergency telephone call predictors for dispatching ambulances with the highest priority level.(Day 0)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Asger Sonne, MD

Principal investigator

Rigshospitalet, Denmark

研究点 (1)

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