跳至主要内容
临床试验/NCT03313258
NCT03313258撤回不适用

The Relationship Between the Use of a Continuous a Zero-heat Flux Temperature Monitor on Initial Discharge Hypothermia Rate Among Severely Injured Trauma Patients: a Randomized Controlled Trial. (RUZIT Trial)

Dr. Asim Alam2 个研究点 分布在 1 个国家开始时间: 2018年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
2
主要终点
Hypothermic (<36°C) upon discharge from the trauma bay

研究概览

简要总结

Hypothermia amongst trauma patients is a persistent problem that increases the relative risk of transfusion as well as morbidity and mortality. The investigators propose to conduct a single-centered randomized controlled trial to determine if the use of a zero-heat flux (ZHF) temperature monitor can reduce the incidence of hypothermia amongst trauma patients discharged from the trauma bay (TB). All eligible trauma patients will be randomized to either a standard of care group or an active temperature monitoring group. In the active temperature monitoring group, a ZHF monitor will be placed on respective trauma patients to continuously record their temperatures after they enter the TB at a large tertiary trauma centre, Sunnybrook Health Sciences Centre (SHSC), in Toronto, ON. The investigators will determine if early continuous temperature monitoring can reduce the incidence of hypothermia upon discharge from the TB. Should early monitoring of severely injured trauma patients within the hospital improves discharge temperature, the foundation for two additional research studies will be laid. Firstly, the investigators will enter a vanguard phase of this trial and assess if early warming patients can improve morbidity and mortality in this patient population utilizing a multi-centered randomized controlled trial design. This will be further extended to test whether early monitoring can be applied in a pre-hospital setting (i.e. within ambulances and transport vehicles) to improve admission temperatures in the TB.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Prevention
盲法
Single (Participant)

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

  • Patients >18 years of age
  • Severely injured trauma patients with a Revised Trauma Score (RTS) ≤ 11 brought into the SHSC TB.

排除标准

  • Patients with blast injuries to the face or severe facial trauma will be excluded.
  • Major burn patients - as they follow a separate care pathway at SHSC

结局指标

主要结局

Hypothermic (<36°C) upon discharge from the trauma bay

时间窗: Duration of their stay in the trauma bay or up to 4 hours in the trauma bay (whichever comes first)

Proportion of patients who are hypothermic (\<36°C) upon discharge from the trauma bay.

次要结局

  • 30 day mortality(Time of admission to discharge or up to 30 days after admission (whichever comes first))
  • Warming initiatives(Duration of their stay in the trauma bay or up to 4 hours in the trauma bay (whichever comes first))
  • Length of stay(Time of admission to discharge or up to 1 year after admission (whichever comes first))
  • Transfused products(Duration of their stay in the trauma bay or up to 4 hours in the trauma bay (whichever comes first))

研究者

发起方
Dr. Asim Alam
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. Asim Alam

MD, FRCPC

Sunnybrook Health Sciences Centre

研究点 (2)

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