Rapid Cool: Heat Stroke Treatment

Обзор

Hot climates such as in Phoenix, AZ commonly have individuals experiencing heat stroke, a life-threatening medical emergency. The dangerously high body temperature can result in death if not treated immediately with rapid body cooling. Rapid core temperature reduction within 30 min of diagnosis results in 100% survival and positive outcomes. While this is easily achieved with whole-body cold water immersion, this modality is not feasible in an ambulance. The Phoenix emergency medical services protocol consists of lying the patient on a large volume of ice. While this is somewhat effective, this cooling strategy results in a sub-optimal cooling rate, difficulty obtaining this large volume of ice, and a very wet ambulance as the ice melts. Recently, a company created a cooling strategy that utilizes a small amount of ice and a small amount of recirculated water to keep the patient cool. The purpose of this study is to determine the core temperature cooling rate of this cooling strategy and compare it to the cooling rate of the currently used Phoenix protocol.

Вмешательства

• Процедура Recirculated water
  Participants will lie in a thick plastic bag with ice and water, placed on top of a cot, with the water circulated using a pump
• Процедура Phoenix protocol
  Participants will lie in a thick plastic bag filled with ice and water, placed on top of a cot

Первичные конечные точки

• Cooling Rate [Срок оценки: 30 minutes post-exercise]

Критерии участия

Критерии включения

• Adult participant (18 - 39 years old)
• Body mass index (BMI) 18 - 30 kg/m2
• At least moderate intensity aerobic exercise ≥60 min per week
• Participant is able and willing to follow study procedures

Критерии исключения

• History of cardiovascular, neurological, metabolic, pulmonary, renal, gastrointestinal, or autoimmune disease
• Taking prescription medication (with exception of psychiatric medication)
• If taking a psychiatric medication, the dosage has changed within the month prior to first study visit
• Cannot abstain from taking over-the-counter medications or supplements for 24 hours before study visits (with exception of vitamins)
• Resting systolic blood pressure ≥130 mmHg and/or diastolic blood pressure ≥90 mmHg
• Resting heart rate of ≥100 beats per minute
• Regular smoker of cigarettes or has regularly smoked in the past year
• Musculoskeletal injury/condition that negatively impacts the protocol
• History of heat illness that resulted in a visit to a medical center in the past 2 years
• Has donated blood or plasma in the past 3 months
• Has taken antibiotics or corticosteroids within 4 weeks of enrollment
• Has a medical implant device such as a pacemaker, patient monitoring system, or metallic implant
• Has a full or partially amputated limb
• Pregnant or breastfeeding
• Study physician or PI discretion based on any other medical condition or medication

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07743619 · STUDY00010755

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗