Hypothermia Rewarming Effectiveness of Distal Limb Warming With Either Fluidotherapy or Warm Water Immersion
Fluidotherapy warming device
Body Temperature Changes+1
+ Signs and Symptoms
+ Pathological Conditions, Signs and Symptoms
Treatment Study
Summary
Study start date: May 1, 2013
Actual date on which the first participant was enrolled.Dr. Gordon Giesbrecht is studying/comparing the effectiveness of heat donation through the distal arms and legs in rewarming a mildly hypothermic individual. Warming will be accomplished through either warm water immersion; and fluidotherapy. Procedure. Eight participants will be cooled in 8°C water on three occasions and then warmed by each of three warming conditions. The study will include following specific procedures: Anthropometric data which includes age, weight, height, and measurements of skinfold thickness at four sites- biceps, triceps, subscapularis, and suprailiac will be collected. Participant's heart rate and electrocardiogram will be monitored continuously throughout the experiment. Participants will be instrumented as follows: About 12 heat flux disks (2 cm in diameter) will be taped to the skin on the arms, legs, torso, head etc. to measure skin temperature and heat transfer from the skin. Three ECG leads will be affixed to the skin. Core temperature will be measured with a disposable esophageal thermocouple. A thin, flexible tube will be inserted through the nose, to midway down the esophagus at the level of the heart. Oxygen consumption will be continuously measured with a metabolic cart. Participants will be asked to wear a face mask which will collect the expired breath during the cooling as well as the rewarming periods. Conditions: The three treatment methods are as follows. A. Spontaneous rewarming (Shivering only) - In this control condition, no external heat will be provided and the participant will rewarm spontaneously with the heat produced from shivering. B. Warm water distal extremities immersion - Distal arms and legs will be immersed in warm water at 45°C for rewarming. C.Fluidotherapy distal extremities rewarming - Distal arms and legs will be immersed in Fluidotherapy equipment for rewarming at 50°C. Rewarming procedures will be administered either for a period of 60 minutes or until core temperature returns to normal values ( ̴ 36.5-37˚C). Following that, participants will be placed in a warm water bath (40-42˚C). Research Design: Each of the three experimental trials, separated by at least 48 hours. On each of the three trials, participants will be immersed up to the level of the sternal notch in 8˚C for up to 60 minutes or until the core temperature falls to 35˚C. The participant will then exit the water, be dried off and rewarmed with either lie inside a vapor barrier within a hooded sleeping bag with the head inside the hood, or sitting with their distal arms and legs immersed in either Fluidotherapy at 50°C or warm water at 45°C. The rewarming will be administered for 60 minutes or until the core temperature returns to normal values (̴36.5-37˚C). The order of warming methods will follow a balanced design.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.8 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 45 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location