NCT02743884

Evaluating Heat Transfer With the Esophageal Cooling Device

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Non-cardiac Surgery

Interventions

Type	Name	Description
DEVICE	Esophageal Warming	30 minutes of warming from circulating water at about 42 degrees C through an esophageal heat exchanger.
DEVICE	Esophageal Cooling	30 minutes of cooling from circulating water at about 7 degrees C through an esophageal heat exchanger.

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2016-04-19
• Last updated: 2017-04-13

Locations

1 site across 1 country: United States