Evaluating Heat Transfer With the Esophageal Cooling Device
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|ClinicalTrials.gov Identifier: NCT02743884|
Recruitment Status : Completed
First Posted : April 19, 2016
Last Update Posted : April 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Non-cardiac Surgery||Device: Esophageal Warming Device: Esophageal Cooling||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Cross-over.|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Prospective, Interventional Study Evaluating Heat Transfer With the Esophageal Cooling Device|
|Actual Study Start Date :||April 2016|
|Actual Primary Completion Date :||January 2017|
|Actual Study Completion Date :||January 2017|
Experimental: Esophageal Cooling Device
Device: Esophageal Cooling
30 minutes of cooling from circulating water at about 7 degrees C through an esophageal heat exchanger.
Experimental: Esophageal Warming
Device: Esophageal Warming
30 minutes of warming from circulating water at about 42 degrees C through an esophageal heat exchanger.
- Mean heat transfer at cooling, kcal/h [ 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
- Mean heat transfer at warming, kcal/h [ 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02743884
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Study Chair:||Daniel Sessler, M.D.||Dept Chairman|