跳至主要内容
临床试验/NCT05963529
NCT05963529已完成不适用

Evaluating the Validity of a Rapid Humidity Ramp Protocol for Identifying the Upper Environmental Limits of Thermal Compensation in Humans

University of Ottawa1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2023年7月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
1
主要终点
Esophageal temperature rate of change

研究概览

简要总结

The global populace is at growing risk of heat-related illness due to climate change and accompanying increases in the intensity and regularity of extremely hot temperatures. In heat-exposed persons, heat gain from the environment and metabolism initially exceeds the rate of heat dissipation from the skin. Heat is stored in the body, causing core and skin temperatures to rise, which in turn triggers autonomically mediated elevations in cutaneous blood flow and sweating to facilitate heat loss. If conditions are compensable, heat loss increases until it balances total heat gain. At this point, the rate of heat storage falls to zero (i.e., heat balance is achieved) and body temperature stabilizes, albeit at a level elevated from thermoneutral conditions. If, however, the maximal achievable rate of heat dissipation is insufficient to offset heat gain, conditions are uncompensable, and prolonged exposure will cause a continual rise in core temperature that can compromise health if left unchecked. The environmental limits of compensability (i.e., the temperatures/humidities above which heat balance can not be maintained) are therefore an important determinant of survival during prolonged heat exposure. Evaluating this limit and how it can be modified (e.g., by behavior or individual factors like age or sex) is an increasingly important and active field of study.

Contemporary evaluations of the environmental limits of compensability utilize "ramping protocols" in which participants are exposed to increasing levels of temperature or humidity (in 5-10 min stages) while core temperature is monitored. It is generally observed that core temperature is relatively stable (or rises slightly) in the early stages of exposure but undergoes an abrupt and rapid increase as heat stress becomes more severe. The conditions (e.g., wet-bulb temperature or wet-bulb globe temperature) at this "inflection point" are taken as the limits of compensability. That is, it is assumed that inflection corresponds to the demarcation point, below which core temperature would remain stable for prolonged periods (theoretically indefinitely if hydration is maintained) but above which heat loss is insufficient to offset heat gain, causing core temperature to rise continuously. Despite the increasing use of these protocols, no study has clearly demonstrated their validity for identifying the environmental limits of compensability. The goal of this project is therefore to assess the validity of ramping protocols for determining the ambient conditions above which thermal compensation is not possible.

Enrolled participants will complete four experimental trials in a climate-controlled chamber: one ramping protocol followed by three randomized fixed-condition exposures. In the ramping protocol, participants will rest in 42°C with 28% relative humidity (RH) for 70 min, after which RH will be increased 3% every 10 min until 70% RH is achieved. The core (esophageal) temperature inflection point will be determined. For the fixed-condition exposures, participants will rest in i) 42°C with RH ~5% below their individual inflection point (below-inflection condition), ii) 42°C with RH ~5% above their individual inflection point (above-inflection condition), and iii) 26°C with 45% RH (control condition). Comparing the rate of change in esophageal temperature between each fixed-condition exposure will provide important insight into the validity of ramping protocols for identifying the limits of compensability.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Participants will be informed of the study interventions before providing informed consent but will be masked to the order the fixed-condition exposures (i.e., participants will not know whether the humidity is above or below their identified inflection point). Data processing and statistical analysis for the fixed-condition exposures will be performed with the analyst blinded to participant and trial conditions.

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Male or female adults.
  • •Aged 18-85 years.
  • •Non-smoking.
  • •English or French speaking.
  • •Ability to provide informed consent.

排除标准

  • •Physical restriction (e.g., due to disease: intermittent claudication, renal impairment, active proliferative retinopathy, unstable cardiac or pulmonary disease, disabling stroke, severe arthritis, etc.).
  • •Use of or changes in medication judged by the patient or investigators to make participation in this study inadvisable (e.g., medications increasing risk of heat-related illness; beta blockers, anticholinergics, etc.)

研究组 & 干预措施

Humidity-ramp protocol

Other

Healthy male and female volunteers. Participants will complete all exposures. The humidity-ramp protocol will necessarily be performed first. The order of the fixed-condition exposures will be randomized.

干预措施: Humidity-ramp protocol (Other)

Above-inflection fixed-condition exposure

Experimental

Healthy male and female volunteers. Participants will complete all exposures. The humidity-ramp protocol will necessarily be performed first. The order of the fixed-condition exposures will be randomized.

干预措施: Above-inflection fixed-condition exposure (Other)

Below-inflection fixed-condition exposure

Experimental

Healthy male and female volunteers. Participants will complete all exposures. The humidity-ramp protocol will necessarily be performed first. The order of the fixed-condition exposures will be randomized.

干预措施: Below-inflection fixed-condition exposure (Other)

Control fixed-condition exposure

Active Comparator

Healthy male and female volunteers. Participants will complete all exposures. The humidity-ramp protocol will necessarily be performed first. The order of the fixed-condition exposures will be randomized.

干预措施: Control fixed-condition exposure (Other)

结局指标

主要结局

Esophageal temperature rate of change

时间窗: End of fixed-condition heat exposure (hour 9 or termination)

Rate of change of esophageal temperature measured over the final 2-hours of heat exposure

Predicted time until 40.2°C esophageal temperature

时间窗: End of fixed-condition heat exposure (hour 9 or termination)

Estimated time for esophageal temperature to reach 40.2°C, a commonly-cited criteria for severe heat-illness (e.g., heat stroke), calculated from the end-exposure esophageal temperature and its rate of change (assuming this rate of change is sustained)

Predicted time until 40.2°C rectal temperature

时间窗: End of fixed-condition heat exposure (hour 9 or termination)

Estimated time for rectal temperature to reach 40.2°C, a commonly-cited criteria for

Rectal temperature rate of change

时间窗: End of fixed-condition heat exposure (hour 9 or termination)

Rate of change of rectal temperature measured over the final 2-hours of heat exposure

次要结局

  • Mean skin temperature rate of change(End of fixed-condition heat exposure (hour 9 or termination))
  • Thermal sensation(End of fixed-condition heat exposure (hour 9 or termination))
  • Net fluid loss(End of fixed-condition heat exposure (hour 9 or termination))
  • Number of participants unable to finish fixed-condition heat exposure(End of fixed-condition heat exposure (hour 9 or termination))
  • Mean skin temperature(End of fixed-condition heat exposure (hour 9 or termination))
  • Heart rate rate of change(End of fixed-condition heat exposure (hour 9 or termination))
  • Esophageal temperature(End of fixed-condition heat exposure (hour 9 or termination))
  • Heart rate(End of fixed-condition heat exposure (hour 9 or termination))
  • Sweat rate(End of fixed-condition heat exposure (hour 9 or termination))
  • Rectal temperature(End of fixed-condition heat exposure (hour 9 or termination))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Glen P. Kenny

Full Professor

University of Ottawa

研究点 (1)

Loading locations...

相似试验