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An esophageal heat exchange tube will be inserted in anesthetized surgical patients. Each patient will have 30 minutes of cooling (circulating fluid at 7 degrees C) and 30 minutes of warming (42 degrees C) with 15-minute recovery break in between. The primary outcome will be heat transfer, determined from inflow and outflow temperatures and fluid flow rate for cooling and warming modes.
The ECD is made with medical-grade silicone and has 3 ports; 2 coolant ports and a central port. The coolant ports of the ECD are connected to external heat exchanger while a third, central lumen simultaneously allows gastric decompression and drainage. The ECD can be inserted like a standard gastric tube.
The aim of this prospective, interventional study is to quantify heat transfer during warming and cooling using the Esophageal Cooling Device in anesthetized patients having non-cardiac surgery.
An esophageal heat exchange tube will be inserted in anesthetized surgical patients. Each will have 30 minutes of cooling (circulating fluid at 7 degrees C) and 30 minutes of warming (42 degrees C) with 15 -minute break in between; the order of the cooling and warming will be randomized. The primary outcome will be heat transfer, determined from inflow and outflow fluid temperatures and fluid flow rate assessed for both cooling and warming modes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Esophageal Cooling Device | Experimental | Esophageal cooling |
|
| Esophageal Warming | Experimental | Esophageal warming |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esophageal Warming | Device | 30 minutes of warming from circulating water at about 42 degrees C through an esophageal heat exchanger. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean heat transfer at cooling, kcal/h | Heat transfer is calculated as difference between inflow and outflow temperatures, multiplied by flow and the specific heat of water | 15-60 minutes after intubation during elective non-cardiac surgery |
| Mean heat transfer at warming, kcal/h | Heat transfer is calculated as difference between inflow and outflow temperatures, multiplied by flow and the specific heat of water | 15-60 minutes after intubation during elective non-cardiac surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Sessler, M.D. | Dept Chairman | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
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Cross-over.
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| Esophageal Cooling | Device | 30 minutes of cooling from circulating water at about 7 degrees C through an esophageal heat exchanger. |
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