IEEM- Work:Rest Cycles in Burn Survivors- Humidity
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorUniversity of Texas Southwestern Medical Center
About this trial
The purpose of this project is to identify the effects of a severe burn injuries in humans on core temperature responses during work:rest cycles while in a heated environment.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Participants must be free of any significant underlying medical problems based upon a detailed medical history and physical exam, and normal resting electrocardiogram. Participants must be between the ages of 18 and 65.
Disqualifiers
Known heart disease; other chronic medical conditions requiring regular medical therapy including cancer, diabetes, neurological diseases, and uncontrolled hypertension, lung disease, etc.; as well as serious abnormalities detected on routine screening. Current smokers, as well as individuals who regularly smoked within the past 3 years will be excluded. Participants may also be excluded if body mass index is ≥ 31 kg/m2 will likewise be excluded. Participants must not have had a serious burn injury requiring more than 1 night stay in the hospital.
Trial population
1. Non-burn control. 2. Individuals 20 - 40% of their body surface area burned. 3. Individuals with greater than 40% of their body surface area burned.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
70 Participants
are grouped into 6 trial groups6
Trial groupsSee each trial group below.
Group A: Non-Burned Individuals in Low Humidity Environment
Group B: Moderate Burned Individuals in Low Humidity Environment
Group C: Large Burned Individuals in Low Humidity Environment
Group D: Non-Burned Individuals in High Humidity Environment
Group E: Moderate Burned Individuals in High Humidity Environment
Group F: Large Burned Individuals in HIgh Humidity Environment
Trial outcomes
Primary outcomes
1
Change in core temperature
Change in core body temperature will be measured either from a temperature sensor pill or from a rectal thermometer.
Time frame
From the start of exercise to the end of the last rest period. Approximately at 0 and 170 minutes.Secondary outcomes
1
Change in Heart Rate
Heart rate will be measured from ECG electrodes attached to the participant.
Time frame
From the start of exercise to the end of the last rest period. Approximately at 0 and 170 minutes.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Texas Southwestern Medical Center
Lead sponsor
Texas Health Resources
Collaborator
Source ClinicalTrials.gov