Evaluating Heat Transfer With the Esophageal Cooling Device

Completed · Not applicable

Conditions studied: Non-cardiac Surgery

In brief

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.

Key facts

Study ID

NCT02743884

Run by

The Cleveland Clinic

People needed

19

Starts

2016-04-01

Expected to finish

2017-01-01

Last updated by the study team

2017-04-13

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Elective non-cardiac surgery;
• Age 18-80 years;
• Surgery expected to last >2 hours;
• General anesthesia with endotracheal Intubation;
• Volatile anesthesia;
• BMI < 38 kg/m2;
• ASA physical status 1-3.

You may not qualify if…

• Weight < 45 kg;
• Unstable blood pressure;
• Known esophageal deformity or evidence of esophageal trauma or esophageal disease that in the opinion of the attending anesthesiologist precludes safe use of ECD.

Where it is running

• Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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