Evaluating Heat Transfer With the Esophageal Cooling Device



Status:Not yet recruiting
Healthy:No
Age Range:18 - 80
Updated:4/21/2016
Start Date:April 2016
End Date:March 2017
Contact:Roberta Johnson
Email:JOHNSOR13@ccf.org
Phone:216 444-9950

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Prospective, Interventional Study Evaluating Heat Transfer With the Esophageal Cooling Device

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.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.
We found this trial at
1
site
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Phone: 216-444-9950
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