Validity of Humidity Ramp Protocols for Identifying Limits of Survivability in Heat-exposed Persons

Temperature Change, Body Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05963529
• Other study ID #: uORamp
• Status: Completed
• Phase: N/A
• Start date: July 14, 2023
• Est. completion date: September 24, 2023

Study information

• Verified date: November 2023
• Source: University of Ottawa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 24, 2023
• Est. primary completion date: September 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Male or female adults.

• Aged 18-85 years.

• Non-smoking.

• English or French speaking.

• Ability to provide informed consent.

Exclusion Criteria:

• 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.)

Related Conditions & MeSH terms

• Body Temperature Changes
• Heat Exposure
• Heat Stress
• Temperature Change, Body
• Temperature; Extreme, Exposure

Intervention

Other:
• Humidity-ramp protocol
Participants are exposed to 42°C and 28% relative humidity for 70 minutes. Thereafter, humidity is increased 3% until an ambient humidity of 70% is achieved. The humidity at which esophageal temperature (and rectal temperature and heart rate) inflect is subsequently determined.
• Above-inflection fixed-condition exposure
After a 1 hour equilibrium at 42°C and 28% relative humidity, humidity will be increased 3% every 10 min until it is ~5% higher than the participants' individual esophageal temperature inflection point identified in the humidity ramp protocol. These conditions will be held constant for the remainder of the 9-hour exposure period (starting from the beginning of equilibrium). Tap water will be provided at regular intervals to limit dehydration.
• Below-inflection fixed-condition exposure
After a 1 hour equilibrium at 42°C and 28% relative humidity, humidity will be increased 3% every 10 min until it is ~5% lower than the participants' individual esophageal temperature inflection point identified in the humidity ramp protocol. These conditions will be held constant for the remainder of the 9-hour exposure period (starting from the beginning of equilibrium). Tap water will be provided at regular intervals to limit dehydration.
• Control fixed-condition exposure
Participants are exposed for 9-hours to 28°C with 35% relative humidity. Participant will be allowed to drink tap water ad libitum.

Locations

Country	Name	City	State
Canada	University of Ottawa	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Ottawa

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Esophageal temperature inflection point	Inflection point for esophageal temperature during the humidity-ramp protocol	During the ramp protocol (up to 2.5 hours)
Other	Rectal temperature inflection point	Inflection point for rectal temperature during the humidity-ramp protocol	During the ramp protocol (up to 2.5 hours)
Other	Heart rate inflection point	Inflection point for heart rate during the humidity-ramp protocol	During the ramp protocol (up to 2.5 hours)
Primary	Esophageal temperature rate of change	Rate of change of esophageal temperature measured over the final 2-hours of heat exposure	End of fixed-condition heat exposure (hour 9 or termination)
Primary	Predicted time until 40.2°C esophageal temperature	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)	End of fixed-condition heat exposure (hour 9 or termination)
Primary	Rectal temperature rate of change	Rate of change of rectal temperature measured over the final 2-hours of heat exposure	End of fixed-condition heat exposure (hour 9 or termination)
Primary	Predicted time until 40.2°C rectal temperature	Estimated time for rectal temperature to reach 40.2°C, a commonly-cited criteria for	End of fixed-condition heat exposure (hour 9 or termination)
Secondary	Number of participants unable to finish fixed-condition heat exposure	Number of participants who could not complete each fixed-condition heat exposure due to participant withdrawal or achieving a core temperature of 39.5°C	End of fixed-condition heat exposure (hour 9 or termination)
Secondary	Mean skin temperature rate of change	Rate of change of skin temperature measured over the final 2-hours of heat exposure	End of fixed-condition heat exposure (hour 9 or termination)
Secondary	Heart rate rate of change	Rate of change of heart rate measured over the final 2-hours of heat exposure	End of fixed-condition heat exposure (hour 9 or termination)
Secondary	Esophageal temperature	Esophageal temperature at the end of the fixed-condition exposures	End of fixed-condition heat exposure (hour 9 or termination)
Secondary	Rectal temperature	Rectal temperature at the end of the fixed-condition exposures	End of fixed-condition heat exposure (hour 9 or termination)
Secondary	Mean skin temperature	Mean skin temperature at the end of the fixed-condition exposures	End of fixed-condition heat exposure (hour 9 or termination)
Secondary	Heart rate	Heart rate at the end of the fixed-condition exposures	End of fixed-condition heat exposure (hour 9 or termination)
Secondary	Thermal sensation	Self-reported thermal sensation at the end of the fixed-condition exposures using and 8-point scale ranging from neutral (0) to extremely hot (8).	End of fixed-condition heat exposure (hour 9 or termination)
Secondary	Sweat rate	Sweat rate at the end of the fixed-condition exposures (calculated via change in body weight)	End of fixed-condition heat exposure (hour 9 or termination)
Secondary	Net fluid loss	Net fluid loss estimated as the percentage change in body mass over the fixed-condition exposures.	End of fixed-condition heat exposure (hour 9 or termination)