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| Name | Class |
|---|---|
| Texas Health Resources | OTHER |
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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.
Non-burned control participants and participants who experienced serious burns covering ≥20% of their body surface area will be investigated. Participants will undergo up to three work:rest cycles in the heat (via our environmental chamber) set to no higher than 40 °C. The work:rest cycle will comprise of 30 min of exercise that is followed by up to 20 min of rest, while staying in the heated conditions. Three consecutive work:rest cycles will be performed as illustrated in the protocol document. During one visit, this protocol will be performed in a low humidity state. During the other visit (randomized and crossover), this protocol will be performed in a high humidity state.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Burned Individuals in Low Humidity Environment | Non-burned individuals will perform up to three work:rest cycles in a heated environment with low humidity, with each work:rest cycle lasting up to 50 minutes. | ||
| Moderate Burned Individuals in Low Humidity Environment | Individuals with moderate sized burn injuries will perform up to three work:rest cycles in a heated environment with low humidity, with each work:rest cycle lasting up to 50 minutes. | ||
| Large Burned Individuals in Low Humidity Environment | Individuals with large sized burn injuries will perform up to three work:rest cycles in a heated environment with low humidity, with each work:rest cycle lasting up to 50 minutes. | ||
| Non-Burned Individuals in High Humidity Environment | Non-burned individuals will perform up to three work:rest cycles in a heated environment with high humidity, with each work:rest cycle lasting up to 50 minutes. | ||
| Moderate Burned Individuals in High Humidity Environment | Individuals with moderate sized burn injuries will perform up to three work:rest cycles in a heated environment with high humidity, with each work:rest cycle lasting up to 50 minutes. | ||
| Large Burned Individuals in HIgh Humidity Environment |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in core temperature | Change in core body temperature will be measured either from a temperature sensor pill or from a rectal thermometer. | From the start of exercise to the end of the last rest period. Approximately at 0 and 170 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Heart Rate | Heart rate will be measured from ECG electrodes attached to the participant. | From the start of exercise to the end of the last rest period. Approximately at 0 and 170 minutes. |
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Inclusion Criteria for Non-burned Individuals:
Exclusion Criteria for Non-burned Individuals:
Inclusion Criteria for Individuals with up to 40% of their body surface area burned (moderate burn group):
- Participants must be free of any significant underlying medical problems based upon a detailed medical history and physical exam, and normal resting electrocardiogram. Participants who have sustained a burn injury must have a burn covering 20-40% of their body surface area and 50% of those burns must be full-thickness burns requiring skin grafts. Participants must be between the ages of 18 and 65.
Exclusion Criteria for Individuals with up to 40% of their body surface area burned (moderate burn group):
- 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.
Inclusion Criteria for Individuals with greater than 40% of their body surface area burned (large burn group):
- Participants must be free of any significant underlying medical problems based upon a detailed medical history and physical exam, and normal resting electrocardiogram. Participants who have sustained a burn injury must have a burn covering more than 40% of their body surface area and 50% of those burns must be full-thickness burns requiring skin grafts. Participants must be between the ages of 18 and 65.
Exclusion Criteria for Individuals with greater than 40% of their body surface area burned (large burn group):
- 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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Craig Crandall, PhD | Contact | 214-345-4623 | craigcrandall@texashealth.org | |
| Erin Harper, BS | Contact | 214-345-4737 | erinharper2@texashealth.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IEEM Texas Health Presbyterian Hospital Dallas | Recruiting | Dallas | Texas | 75231 | United States |
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| ID | Term |
|---|---|
| D000084462 | Hyperthermia |
| D002056 | Burns |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018882 | Heat Stress Disorders |
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Individuals with large sized burn injuries will perform up to three work:rest cycles in a heated environment with high humidity, with each work:rest cycle lasting up to 50 minutes. |
| D014947 | Wounds and Injuries |