Development of a Novel Cooling Vest to Prevent Heat-Induced Thermoregulatory Dysfunction in Persons with Spinal Cord Injury

开发新型降温背心以预防脊髓损伤患者因热引起的体温调节功能障碍

• 批准号: 10701833
• 负责人: John P Handrakis
• 金额: --
• 依托单位: JAMES J PETERS VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-11-01 至 2024-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10701833
• 关键词: Address; Adverse effects; Affect; Attenuated; Autonomic Pathways; Biomedical Engineering; Body Temperature; Brain; Cervical spinal cord injury; Cessation of life; Collaborations; Compensation; Cutaneous; Development; Effectiveness; Ensure; Environment; Esthesia; Experimental Designs; Exposure to; Fatigue; Feedback; Feeling; Functional disorder; Goals; Health; Heat Exhaustion; Heat Losses; Heat Stress Disorders; Heat Stroke; Heat Waves; Homeostasis; Hour; Human Engineering; Hyperthermia; Hypothalamic structure; Impaired cognition; Impairment; Increased sweating; Injury; Interruption; Intervention; Investigation; Laboratory Research; Lesion; Letters; Liquid substance; Maintenance; Marketing; Measures; Medical; Methods; Motor; Normal Range; Organ failure; Pacific Northwest; Participant; Pathway interactions; Perception; Performance; Persons; Physiologic Thermoregulation; Pilot Projects; Positioning Attribute; Quadriplegia; Quality of life; Regulation; Religion; Reporting; Research Personnel; Risk; Safety; Seasons; Seizures; Sensory; Shivering; Skin Temperature; Spinal cord injury; Spottings; Sunlight; Sweating; Technology Transfer; Temperature; Testing; Thinking; Travel; Unconscious State; Vasodilation; Vasomotor; Veterans; Work; body system; climate zone; cold injury; design; efficacy evaluation; efficacy testing; experience; home test; hot climate; human subject; improved; military veteran; novel; prevent; programs; prototype; recruit; safety testing; social; thoracic vertebra bone structure; vasoconstriction; warm temperature

Persons with spinal cord injury (SCI), particularly those with injuries above T6 (Hi-SCI), are unable to effectively regulate core body temperature (Tcore) due to interruption of motor, sensory, and sympathetic pathways. Interruption of sympathetic pathways limits central regulation of vasodilation and sweating for increasing heat loss and vasoconstriction for decreasing heat loss. Thus, when exposed to ambient heat, limited control of cutaneous vasodilation and sweating impairs the ability to maintain a constant Tcore. Persons with Hi-SCI often find themselves in hot environments for prolonged periods during social, religious, or work functions, especially during warmer seasons or when in hot climate zones. They report rapidly progressing to feeling “overheated,” uncomfortable, and fatigued during even limited exposure to conditions considered as mildly hot by able-bodied (AB) controls. During these times, their dramatic rise in Tcore can reach hyperthermia (≥38°C) and, if allowed to progress, can lead to heat stroke, causing seizures, loss of consciousness, and potentially death. Interventions that address the increased risk for heat-related illness in persons with SCI are limited. Therefore, continuing development of our feedback-controlled ”smart” cooling vest and testing its safety and efficacy to sufficiently dissipate body heat to compensate for thermodysregulation, is absolutely vital to minimize the adverse effects on health and quality of life that most Veterans with Hi-SCI experience during exposure to warm temperatures. The goals of this pilot study are to: 1) further develop and test the safety and tolerability of a self-regulating cooling vest in AB participants, and 2) determine the efficacy of the cooling vest to provide protection from an excessive rise in Tcore and thermal discomfort during warm exposure in Veterans with Hi-SCI. Five AB participants and ten participants with Hi-SCI (C4-T2, AIS A-B) will be recruited for study. AB participants will be observed to ensure the safety of the vest, which will be determined by assessing skin temperatures and subjective thermal sensation beneath the vest during 2 hours of warm exposure (35°C). In participants with Hi- SCI during 2 hours of warm exposure (35°C), a repeated measures experimental design for [two-conditions (wet vest, no vest)] is being proposed to demonstrate the efficacy of the cooling vest to attenuate the expected rise in Tcore and thermal discomfort. Primary Objective (Safety): In a warm thermal chamber (35°C), AB participants will wear the wet cooling vest at maximal setting for 2 hours in the seated position to determine: (1) minimum skin temperatures beneath the wet cooling vest, and (2) subjective comfort of the wet cooling vest (safety testing). Primary Hypotheses: AB participants will demonstrate (1) All skin temperatures beneath the vest will be ≥20°C. (2) All participants will report a thermal sensation (TS) ≥ “cool” (not “cold” or “very cold”) (Zhang 9-point Thermal Sensation scale). Secondary Objective (Efficacy in SCI): On 2 separate days, participants with Hi-SCI will wear either the wet cooling vest [or no vest] (in random order) for up to 2 hours in the seated position in a warm thermal chamber (35°C) to determine: (1) change in Tcore, and (2) change in thermal comfort (efficacy testing). Secondary Hypotheses: Participants with Hi-SCI wearing the wet cooling vest when in the warm environment will have the following findings: 1) 65% will demonstrate a significantly reduced elevation in Tcore (≤0.3°C) than the expected mean increase (0.6±0.3°C) in the [no vest condition], and 2) a greater percentage of participants with SCI will report a decreased perception of heat and thermal discomfort (Zhang 6-point Thermal Comfort scale) than the expected perceptions of “hot or very hot” and “uncomfortable” that will be reported in the [no vest condition].

脊髓损伤的人（SCI），尤其是T6高于T6（HI-SCI）的人，无法有效 由于电动机，感觉和交感神经途径的中断，调节核心体温（TCORE）。 交感道路的中断限制了血管舒张和出汗以增加热量的中心调节 减少热量损失的损失和血管收缩。当暴露于环境热量时，对 皮肤血管舒张和出汗会损害保持恒定TCORE的能力。经常患有hi-sci的人 在社会，宗教或工作功能期间，发现自己在炎热的环境中，尤其是 在温暖的季节或在炎热的气候区域中。他们报告迅速发展为“过热”， 不舒服，甚至在有限的情况下，由于身体强壮而被视为有些热的条件，也会疲劳 （AB）控件。在这些时候，它们在Tcore中的急剧上升可以达到高温（≥38°C），如果允许 进步会导致中风，导致癫痫发作，意识丧失以及潜在的死亡。 解决SCI患者中与热有关的疾病风险的增加是有限的。因此，继续 开发我们反馈控制的“智能”冷却背心，并测试其安全性和有效性 散发体内热量以补偿热发育，对于最大程度地减少不良反应至关重要 关于大多数在暴露温度温度的退伍军人的健康和生活质量。 该试点研究的目标是：1）进一步发展和测试自我调节的安全性和耐受性 在AB参与者中冷却背心，以及2）确定冷却背心的效率 HI-SCI退伍军人温暖暴露期间TCORE和热不适的过度上升。五个AB 将招募参加HI-SCI（C4-T2，AIS A-B）的参与者和10名参与者进行研究。 AB参与者将 观察到是为了确保背心的安全，这将通过评估皮肤温度和 在温暖暴露（35°C）的2小时内，在背心下方受到的热感觉。在hi-的参与者中 在温暖暴露（35°C）的2小时内，SCI进行了重复的措施[两条条件（湿） 背心，没有背心）。 在TCORE和热不适中。 主要目标（安全）：在温暖的热室（35°C）中，AB参与者将穿湿冷却背心 在最大设置座位的位置2小时以确定：（1）在下面的最低皮肤温度 湿冷却背心和（2）湿冷却背心的主观舒适度（安全测试）。 主要假设：AB参与者将证明（1）背心下面的所有皮肤温度均为≥20°C。 （2）所有参与者将报告热感觉（TS）≥“酷”（不是“冷”或“非常冷”）（张9点热力 感觉量表）。 次要目标（SCI的功效）：在两天的时间里，HI-SCI的参与者将穿湿 冷却背心（或无背心）（随机顺序）在温暖的热室中最多2小时 （35°C）确定：（1）TCORE的变化，（2）改变热舒适度（功效测试）。 次要假设：在温暖的环境中，HI-SCI的参与者穿着湿冷却背心 将有以下发现：1）65％的TCORE升高（≤0.3°C）将显着降低。 比[无背心条件]预期的平均增加（0.6±0.3°C），2）更大的百分比 SCI的参与者将报告热量和热不适感（Zhang 6分热量）的感知减少 舒适度）比预期的“热或非常热”和“不舒服”的看法将在 [无背心条件]。