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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
Sponsor:
Information provided by (Responsible Party):
d sessler, The Cleveland Clinic

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.

Condition or disease Intervention/treatment Phase
Non-cardiac Surgery Device: Esophageal Warming Device: Esophageal Cooling Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
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

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.




Primary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Study Chair: Daniel Sessler, M.D. Dept Chairman

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Responsible Party: d sessler, Chair Department of Outcomes Research, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02743884     History of Changes
Other Study ID Numbers: 16-124
First Posted: April 19, 2016    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No