Study of a New Clinical Device for Reducing Body Core Temperature
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 4
- 主要终点
- Adverse Events From Application and Use of the Core Cooling System (CCS) Device.
研究概览
简要总结
This is a descriptive, nonrandomized, noninvasive, single-group, single-center pilot study of a Core Cooling System (CCS) device for reducing core body temperature in ICU patients at University Medical Center Brackenridge (UMCB) and Seton Medical Center Austin (SMCA). The proposed research on human subjects will provide data that will be used to improve a specialized human heat transfer technique/device. By stimulating specialized blood vessels (arteriovenous anastomoses) AVAs in the palm of the hand, it is possible to greatly increase local blood flow and thus greatly increase the potential for effective heat transfer between the environment and body.
The hypothesis of this trial is that the Core Cooling System (CCS) will prove to be a practical, safe, and effective method to raise or lower body temperature in critically ill patients.
详细描述
Introduction:
The ability to manipulate body core temperatures quickly and effectively would impact a number of fields, with truly transformative potential. By far the best way to effect a change in body temperature is perfusion with cooled or warmed blood because the vasculature of the human body equilibrates magnificently well with the body and especially the body core tissues due to the diffuse microcirculation. This process is quite invasive, however, and noninvasive techniques to date have mostly revolved around various surface heat transfer mechanisms that ultimately rely on relatively inferior conduction heat transfer.
Grahn, et al., at Stanford University have identified a new technique to increase the rate of heat transfer between the skin and the body core by up to a factor of ten by harnessing the convective power of the circulatory system in a completely noninvasive way [1, 2]. Our system is derivative of the Stanford device, but different in many significant ways.
A well-understood and thus modifiable system capable of rapid artificial heat transfer has almost limitless potential applications, including treatment of acute brain trauma (where the single greatest challenge to treatment is inducing immediate hypothermia), athletic performance enhancement, military operations, and enhancement of industries in which workers are subject to extreme thermal stress.
Description of the Technology/Device:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age ≥ 18 years
- •Admitted to UMCB ICU
- •Sedated, intubated and or mechanically ventilated
- •At least one core temperature measurement device in place (rectal, bladder, pulmonary artery) as standard of care
- •Medical/surgical condition is stable enough to permit uninterrupted testing and observation for at least 24 hours
- •No medical/surgical procedures are anticipated as necessary or scheduled during testing and observation period that would be affected by this protocol
- •Vital signs and other parameters have been stable for at least 12 hours and there are no imminent indications of instability
- •LAR available and willing to provide informed consent
排除标准
- •Condition is too unstable to permit uninterrupted testing and observation
- •Pregnant and breast feeding patients
- •Patients that might worsen with TH, including coagulopathy (INR>1.5), thrombocytopenia (platelet count <100,000)
- •Patients on antiplatelet therapy other than aspirin
- •Patients on anticoagulants other than prophylactic low molecular weight heparin
- •Patients on pressors to maintain blood pressure
- •Patients with injuries to extremities that could preclude application of cooling mittens or socks to at least three extremities
- •Patients on TH treatment for any other condition
结局指标
主要结局
Adverse Events From Application and Use of the Core Cooling System (CCS) Device.
时间窗: 1 year after the enrollment is closed
1. Assess and capture all adverse events (if any) from application and use of the CCS device. 2. Also assess CCS device interference with participant's standard of care.
次要结局
- Number of Participant's With Adverse Events From Induction of Therapeutic Hypothermia (TH).(1 year after the enrollment is closed.)