Cleveland Clinic
Cleveland, Ohio, 44195, United States
NCT Number: NCT02743884
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.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Cleveland, Ohio, 44195, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
30 minutes of warming from circulating water at about 42 degrees C through an esophageal heat exchanger.
30 minutes of cooling from circulating water at about 7 degrees C through an esophageal heat exchanger.
Time frame: 15-60 minutes after intubation during elective non-cardiac surgery
Heat transfer is calculated as difference between inflow and outflow temperatures, multiplied by flow and the specific heat of water
Time frame: 15-60 minutes after intubation during elective non-cardiac surgery
Heat transfer is calculated as difference between inflow and outflow temperatures, multiplied by flow and the specific heat of water
The Cleveland Clinic
Other
Prospective, Interventional Study Evaluating Heat Transfer With the Esophageal Cooling Device
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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