Evaluating Heat Transfer With the Esophageal Cooling Device

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.

Study Overview

• Status: Completed
• Conditions: Non-cardiac Surgery
• Intervention / Treatment: Device: Esophageal Cooling; Device: Esophageal Warming

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Esophageal Cooling Device; Esophageal cooling	Device: Esophageal Cooling; 30 minutes of cooling from circulating water at about 7 degrees C through an esophageal heat exchanger.
Experimental: Esophageal Warming; Esophageal warming	Device: Esophageal Warming; 30 minutes of warming from circulating water at about 42 degrees C through an esophageal heat exchanger.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Study Chair: Daniel Sessler, M.D., Dept Chairman

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: April 14, 2016
• First Submitted That Met QC Criteria: April 15, 2016
• First Posted (Estimate): April 19, 2016

Study Record Updates

• Last Update Posted (Actual): April 13, 2017
• Last Update Submitted That Met QC Criteria: April 11, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 16-124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No