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 (SCI) 患者，尤其是 T6 以上损伤 (Hi-SCI) 的患者，无法有效地 由于运动、感觉和交感神经通路的中断而调节核心体温 (Tcore)。 交感神经通路的中断限制了血管舒张和出汗以增加热量的中枢调节 因此，当暴露于环境热量时，对热量的控制有限。 皮肤血管舒张和出汗通常会损害 Hi-SCI 患者维持恒定 Tcore 的能力。 在社交、宗教或工作活动中发现自己长时间处于炎热的环境中，尤其是 他们报告说，在温暖的季节或在炎热的气候地区，他们会迅速感到“过热”。 即使在有限的暴露于身体健全者认为微热的条件下也会感到不舒服和疲劳 (AB) 对照期间，它们的 Tcore 急剧上升可达到高温 (≥38°C)，并且如果允许的话。 进展，可能导致中暑、癫痫发作、意识丧失，甚至可能死亡。 解决 SCI 患者因热相关疾病风险增加的方法是有限的，因此，继续进行。 开发我们的反馈控制“智能”冷却背心并充分测试其安全性和有效性 散发体温以补偿热失调，对于最大限度地减少不利影响绝对至关重要 大多数患有 Hi-SCI 的退伍军人在暴露于温暖温度下时所经历的健康和生活质量。 该试点研究的目标是：1）进一步开发和测试自我调节的安全性和耐受性 AB 参与者穿着降温背心，以及 2) 确定降温背心提供保护的功效 患有 Hi-SCI 的退伍军人在温暖暴露期间 Tcore 过度升高和热不适。 将招募 10 名具有 Hi-SCI（C4-T2、AIS A-B）的参与者进行研究。 观察以确保背心的安全，这将通过评估皮肤温度和 患有 Hi- 的参与者在主观的 2 小时温暖暴露（35°C）期间背心下方的热感觉。 SCI 在 2 小时的温热暴露 (35°C) 期间，重复测量实验设计[两种条件（湿 背心，无背心）]正在提议证明冷却背心减弱预期上升的功效 Tcore 和热不适。 主要目标（安全）：在温暖的热室（35°C）中，AB 参与者将穿着湿冷却背心 在最大设置下坐姿 2 小时，以确定：(1) 身体下方的最低皮肤温度 湿式冷却背心，以及（2）湿式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) 背心下方的所有皮肤温度将≥20°C。 （2）所有参与者都会报告热感觉（TS）≥“凉”（不是“冷”或“非常冷”）（张9点热感） 感觉等级）。 次要目标（SCI 中的功效）：在 2 个不同的日子里，患有 Hi-SCI 的参与者将穿着湿式 冷却背心[或无背心]（随机顺序）在温暖的热室中坐姿长达 2 小时 (35°C) 以确定：(1) Tcore 的变化，以及 (2) 热舒适度的变化（功效测试）。 次要假设：Hi-SCI 参与者在温暖的环境中穿着湿式冷却背心 将有以下结果：1) 65% 将表现出 Tcore 升高显着降低 (≤0.3°C) 比 [无背心条件] 下的预期平均升高 (0.6±0.3°C) 更高，并且 2) 患有 SCI 的参与者会报告热感和热不适感下降（Zhang 6 点热 舒适度）高于将在报告中报告的“热或非常热”和“不舒服”的预期感知 [无归属条件]。