The Effect of Active External Rewarming on Rewarming Rate in Simulated Prehospital Accidental Hypothermia - an Experimental Field Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Core body temperature
研究概览
简要总结
In this study, we aim to compare the effect of active external rewarming to passive rewarming in healthy research participants on core temperature.
The participants will be cooled to a core temperature of 35 degress C, the rewarmed using 2 different scenarios. Scenario 1 will be with passive rewarming, scenario 2 with active rewarming. Shivering will be pharmacologically inhibited using Buspirone and Meperidine.
详细描述
Accidental hypothermia is defined as an involuntary drop in core body temperature below 35°C. Hypothermia is a risk factor for cardiac arrythmia, pulmonary oedema, coagulopathy and neurological pathology. Isolated accidental hypothermia is potentially lethal on its own, and it is also an independent risk factor for increased mortality in patients with traumatic injury.
When core temperature drops, the body will automatically activate compensatory mechanisms in order to both increase thermic production and minimize heat loss in order to restore normal temperature. The mechanisms for thermal homeostasis are complex, strictly regulated and effective.
Until quite recently, active external rewarming was considered to be harmful and dangerous for patients with accidental hypothermia. A fear of fatal complications such as increased afterdrop and "rearming syndrome" leading to dangerous arrythmias and a drop in blood pressure which in a worst case scenario could lead to circulatory collapse, shock and potentially death.
Given the potentially detrimental consequences of being cold, any advice to abstain from warming patients should be well-documented, and the adverse effects of warming should outweigh those of being hypothermic. The lack of evidence for this claim that active external rewarming is dangerous along with many reports of successful external rewarming is leading to a change in most guidelines where active external rewarming is now an advisable treatment option.
A variety of different technological devices exist for the purpose of rewarming, but there is no established standard which is proven superior to others. Several trials have compared different rewarming methods, but evidence is limited. There is particularly deficient evidence regarding the amount of heat available for transfer from different methods and also the required amount of heat transfer for the rewarming to have a significant clinical impact.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants are eligible to be included in the study only if all of the following criteria apply:
- •Participant must be over 18 and under 40 years of age at the time of signing the informed consent.
- •Type of Participant and Disease Characteristics
- •Participants who are overtly healthy as determined by their medical history. The participants will be asked to fill out a health-report stating to be healthy, using no relevant medication, and having no relevant allergies or hypersensitivity to the active substances or to any of the excipients of the medications used.
- •BMI under 30 kg/m2 Sex and Contraceptive/Barrier Requirements
- •Both male and female participants can be included. Female participants of childbearing potential will be asked to take a pregnancy test to confirm the absence of pregnancy prior to study drug administration on both visit 1 and
- •Informed Consent
- •Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
排除标准
- •Ahead of trial the participants will be contacted by a medical physician in the research group who will go through a medical questionnaire mainly based on the SmPC of Meperidine, Buspirone and Sodium chloride in "Felleskatalogen" with the following exclusion criteria.
- •Drugs: Concomitant use of sedatives, MAO-inhibitors, SSRI, ritonavir, cimetidine, chlorpromazine, phenytoin, erythromycin, itraconazole, platelet inhibitors, Apomorphine, alcohol (during the trial period) or other opioids or opioid antagonists (during the trial period). History of drug dependency.
- •Recent head injury (last. 12 months), known increased ICP, seizures or epilepsy
- •Other: Known reduced liver- or kidney function, reduced respiratory drive, known supraventricular tachycardia or prolonged QTc, hypertrophy of the prostate or urinary constriction, ongoing pregnancy or breastfeeding. Known acute glaucoma, myasthenia gravis. Previous abdominal surgery. History of cold injuries or frostbites.
- •Planned MRI the next two days after ingestion of temperature capsule.
结局指标
主要结局
Core body temperature
时间窗: 2 hour cooling phase, 1 hour rewarming phase
Esophageal measurement
次要结局
未报告次要终点