Topics

Prospective, Interventional Study Evaluating the Feasibility and Safety of the Esophageal Cooling Device

2015-04-23 14:08:22 | BioPortfolio

Summary

The aim of this prospective, interventional study is to assess the feasibility and safety of the Esophageal Cooling Device in patients from suffering from traumatic brain injury who the treating physician is treating with targeted temperature management. Comparison of outcomes will be made to historical controls. The primary outcome is the feasibility of inducing, maintaining, and rewarming patients from targeted temperature management using the Esophageal Cooling Device (cooling rate, rewarming rate, and the percent of time within goal temperature during the goal-temperature maintenance period). Evaluation of adverse events (including cardiac arrhythmias, severe bradycardia, myocardial infarction/re-infarction, dysphagia, odynophagia, aspiration pneumonia, non-aspiration pneumonia, reflux, esophageal injury, and esophagitis) will be closely monitored during the whole period of targeted temperature management (secondary endpoint).

Description

Controlling patient's body temperature, and in particular, reducing body temperature in a treatment referred to as targeted temperature management, has been shown to improve outcomes for many conditions, including neonatal hypoxic ischemic encephalopathy, cardiac arrest, and traumatic brain injury. However, available modalities for inducing targeted temperature management have a number of technical, logistical, and financial barriers. The Esophageal Cooling Device is a multi-chambered silicone tube placed in the esophagus that provides a highly efficient heat transfer to or from a patient.

Traumatic brain injury (TBI) is a major cause of death and severe disability throughout the world. Current methods of traumatic brain injury treatment include reduction of brain swelling and edema, both by surgical means, as well as by reduction of temperature and avoidance of fever. Methods used to reduce temperature and control fever include surface devices, such as ice packs and water circulating blankets, and intravascular catheters, which are placed into a blood vessel.

The esophagus is in close proximity to blood flow from the heart and great vessels, and the Esophageal Cooling Device (ECD) is designed to take advantage of this heat exchange environment. The ECD's ability to decompress the stomach and avoid distention of the esophagus away from the device ensures good contact with the esophageal mucosa, and thus maximizes heat transfer from the patient. The ECD replaces the standard gastric tube which is placed in the target patient population as a routine standard of care, is made of standard medical-grade silicone, and is generally similar in size and shape to the gastric tubes currently used. Initial mathematical, animal, and human data have shown strong support for the efficacy and safety of the ECD.

The aim of this prospective, interventional study is to assess the feasibility and safety of the Esophageal Cooling Device in patients from suffering from traumatic brain injury who the treating physician is treating with targeted temperature management. Comparison of outcomes will be made to historical controls. The primary outcome is the feasibility of inducing, maintaining, and rewarming patients from targeted temperature management using the Esophageal Cooling Device (cooling rate, rewarming rate, and the percent of time within goal temperature during the goal-temperature maintenance period). Evaluation of adverse events (including cardiac arrhythmias, severe bradycardia, myocardial infarction/re-infarction, dysphagia, odynophagia, aspiration pneumonia, non-aspiration pneumonia, reflux, esophageal injury, and esophagitis) will be closely monitored during the whole period of targeted temperature management (secondary endpoint).

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Conditions

Traumatic Brain Injury

Intervention

Esophageal Cooling Device (ECD), manufactured by Advanced Cooling Therapy, Inc.

Status

Not yet recruiting

Source

Advanced Cooling Therapy, LLC

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-04-23T14:08:22-0400

Clinical Trials [3196 Associated Clinical Trials listed on BioPortfolio]

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 warmi...

Esophageal Cooling for AF Ablation

The purpose of this study is to determine if esophageal cooling using the Attune Medical Esophageal Heat Transfer Device (EnsoETM) limits the number or seriousness of injury to the esophag...

Study to Evaluate the Effects of the Cooling Bolero in Women With Common Menopause Symptoms

The Cooling Bolero is a gel-filled vest manufactured by Nanohealth. It is a cool therapy device intended to provide moderate cooling (~15C/59F) through indirect contact with the skin. The ...

Study to Evaluate the Effects of the Cooling Bolero in Women With Menopause Symptoms

The Cooling Bolero is a vest filled with a new material (not ice or a gel) that provides controlled cooling by absorbed heat. The vest is manufactured by Nanohealth. It intended to provide...

Tarp Assisted Cooling of Hyperthermic Individuals

This is a randomized controlled trial exploring the difference in cooling rates between two treatments: 1) tarp-assisted cooling and 2) the standard of care for heat stroke treatment in th...

PubMed Articles [16493 Associated PubMed Articles listed on BioPortfolio]

Esophageal cooling for protection during left atrial ablation: a systematic review and meta-analysis.

Thermal damage to the esophagus is a risk from radiofrequency (RF) ablation of the left atrium for the treatment of atrial fibrillation (AF). The most extreme type of thermal injury results in atrio-e...

Impact of an intra-abdominal cooling device during open kidney transplantation in pigs.

Transplantation of kidneys from deceased donors is still associated with a high rate of postoperative renal dysfunction. During implantation into the recipient, the kidney rewarms. This second warm is...

Mechanical feedback cooling assisted by optical cavity cooling of the thermal vibration of a microcantilever.

This study describes a new two-step process to cool the thermal vibration of microcantilevers. The process combines active mechanical feedback cooling and optical cavity cooling. A micro-Fabry-Perot i...

Transpiration cooling with bio-inspired structured surfaces.

Transpiration cooling is considered to be one of the most effective cooling methods to protect components from ablation in extremely high temperature environments, so improving transpiration cooling e...

Single Nanoporous MgHPO·1.2HO for Daytime Radiative Cooling.

Objects can radiate emission of heat to outer empty space (3 K) through an atmospheric window (8-13 μm), resulting in a possibility for radiative cooling. Multilayer film stacking designs and complex...

Medical and Biotech [MESH] Definitions

ANESTHESIA achieved by lowering either BODY TEMPERATURE (core cooling) or SKIN TEMPERATURE (external cooling).

The mechanical process of cooling.

The transformation of a liquid to a glassy solid i.e., without the formation of crystals during the cooling process.

A chlorinated hydrocarbon used as an industrial solvent and cooling liquid in electrical transformers. It is a potential carcinogen.

The processes of heating and cooling that an organism uses to control its temperature.

More From BioPortfolio on "Prospective, Interventional Study Evaluating the Feasibility and Safety of the Esophageal Cooling Device"

Quick Search

Relevant Topics

Anxiety Disorders
Anxiety is caused by stress. It is a natural reaction, and is beneficial in helping us deal with tense situations and pressure. It is deterimental when is becomes an excessive, irrational dread of everyday situations. The most common types of anxiety di...

Alzheimer's Disease
Of all the types of Dementia, Alzheimer's disease is the most common, affecting around 465,000 people in the UK. Neurons in the brain die, becuase  'plaques' and 'tangles' (mis-folded proteins) form in the brain. People with Al...


Searches Linking to this Trial