Evaluating Heat Transfer With the Esophageal Cooling Device

Non-cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02743884
• Other study ID #: 16-124
• Status: Completed
• Phase: N/A
• First received: April 14, 2016
• Last updated: April 11, 2017
• Start date: April 2016
• Est. completion date: January 2017

Study information

• Verified date: April 2017
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Non-cardiac Surgery

Intervention

Device:
• Esophageal Warming
30 minutes of warming from circulating water at about 42 degrees C through an esophageal heat exchanger.
• Esophageal Cooling
30 minutes of cooling from circulating water at about 7 degrees C through an esophageal heat exchanger.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean heat transfer at cooling, kcal/h	Heat transfer is calculated as difference between inflow and outflow temperatures, multiplied by flow and the specific heat of water	15-60 minutes after intubation during elective non-cardiac surgery
Primary	Mean heat transfer at warming, kcal/h	Heat transfer is calculated as difference between inflow and outflow temperatures, multiplied by flow and the specific heat of water	15-60 minutes after intubation during elective non-cardiac surgery