Evaluating Heat Transfer With the Esophageal Cooling Device

NCT ID: NCT02743884

Last Updated: 2017-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2017-01-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Esophageal Cooling Device

Esophageal cooling

Group Type: EXPERIMENTAL

Esophageal Cooling

Intervention Type: DEVICE

30 minutes of cooling from circulating water at about 7 degrees C through an esophageal heat exchanger.

Esophageal Warming

Esophageal warming

Group Type: EXPERIMENTAL

Esophageal Warming

Intervention Type: DEVICE

30 minutes of warming from circulating water at about 42 degrees C through an esophageal heat exchanger.

Interventions

Esophageal Warming

30 minutes of warming from circulating water at about 42 degrees C through an esophageal heat exchanger.

Intervention Type: DEVICE

Esophageal Cooling

30 minutes of cooling from circulating water at about 7 degrees C through an esophageal heat exchanger.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

d sessler

Chair Department of Outcomes Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Sessler, M.D.

Role: STUDY_CHAIR

Dept Chairman

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

16-124

Identifier Type: -

Identifier Source: org_study_id