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临床试验/NCT05908630
NCT05908630已完成不适用

The Role of Accidental Hypothermia in Drowning-related Out-of-hospital Cardiac Arrest: A Danish Six-year Observational Cohort Study

Prehospital Center, Region Zealand1 个研究点 分布在 1 个国家目标入组 119 人开始时间: 2023年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
119
试验地点
1
主要终点
Survival or poor neurological outcome

研究概览

简要总结

This study aims to report mortality and neurological outcome 180 days after drowning incident in patients with accidental hypothermia vs normothermia following drowning-related OHCA in Denmark during a six-year period from 2016-2021.

详细描述

The incidence of accidental hypothermia in patients with out-of-hospital cardiac arrest (OHCA) due to drowning is prevalent. Accidental hypothermia is known to decrease oxygen consumption and hypoxic brain damage in patients with OHCA, but may result from prolonged submersion times, which is shown to increase drowning mortality and morbidity. However, many case reports present extraordinary instances of hypothermic patients with drowning-related OHCA surviving with a good neurological outcome despite prolonged submersion times. A larger, retrospective study is warranted to accurately investigate the role of accidental hypothermia in patients with drowning-related OHCA.

This study is a nationwide, retrospective cohort study with 180-days follow-up from 2016-2021 comparing survival and neurological outcome 180 days after drowning incident in normothermic (≥35C) vs hypothermic (<35C) patients with drowning-related OHCA. A total of 317 patients have been identified by the Danish Drowning Formula and manually validated (Breindahl et al, 2023, unpublished data). Prehospital data from the DCAR will be linked to in-hospital data using the patients' unique civil registration number and presented the "Utstein style". The primary outcome is composite of mortality or poor neurological outcome 180 days after drowning incident (modified Rankin Scale score > 3). Secondary outcomes include hospital length of stay (continuous), intensive care unit admission (binary) and length of stay (continuous), need for ECLS (binary) and duration (continuous), need for mechanical ventilation (binary) and duration (continuous), survival to hospital discharge, and 30-day survival.

The investigators expect to provide evidence on the role of accidental hypothermia in drowning-related OHCA to support evidence-based guidelines and improve clinical decision-making in the future.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Survival or poor neurological outcome

时间窗: 180 days after drowning incident.

The primary outcome is a composite of mortality or poor neurological outcome 180 days after drowning incident according to the Utstein style

次要结局

  • Hospital length of stay(Immediately after hospital discharge)
  • Intensive care unit admission(Immediately after hospital discharge)
  • Survival to hospital discharge(Immediately after hospital discharge)
  • Duration of ECLS(Immediately after hospital discharge)
  • Need for mechanical ventilation(Immediately after hospital discharge)
  • 30-day survival(30 days after drowning incident)
  • Intensive care unit length of stay(Immediately after hospital discharge)
  • Need for ECLS(Immediately after hospital discharge)
  • Duration of mechanical ventilation(Immediately after hospital discharge)

研究者

发起方
Prehospital Center, Region Zealand
申办方类型
Other
责任方
Principal Investigator
主要研究者

Niklas Breindahl

Medical Doctor

Prehospital Center, Region Zealand

研究点 (1)

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