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Completed

NCT Number: NCT02743884

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.

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Esophageal warming

Device

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

Esophageal Cooling

Device

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 19, 2016
Registry last updated
Apr 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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