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）的人，特别是T6以上的损伤（Hi-SCI），无法有效地