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

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ClinicalTrials.gov Identifier: NCT02420639
Recruitment Status : Completed
First Posted : April 20, 2015
Last Update Posted : December 19, 2017
Sponsor:
Collaborator:
Dnipropetrovsk State Medical Academy
Information provided by (Responsible Party):
Advanced Cooling Therapy, LLC

Brief 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).

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Device: Esophageal Cooling Device (ECD), manufactured by Advanced Cooling Therapy, Inc. Not Applicable

Detailed 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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Prospective, Interventional Study Evaluating the Feasibility and Safety of the Esophageal Cooling Device in 15 Patients Suffering From Traumatic Brain Injury and Treated With Targeted Temperature Management
Study Start Date : August 2015
Actual Primary Completion Date : August 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
The placement of the Esophageal Cooling Device will follow standard recommendations as per Instructions for Use. The Esophageal Cooling Device will be connected to the appropriate console (Meditherm III, Blanketrol II, or Blanketrol III).
Device: Esophageal Cooling Device (ECD), manufactured by Advanced Cooling Therapy, Inc.
Use of the Esophageal Cooling Device for control of patient temperature.




Primary Outcome Measures :
  1. Time to initiation of temperature management [ Time Frame: 30 days ]
    Time to initiation of targeted temperature management, as measured from the time a decision is made to begin targeted temperature management, to the time the esophageal cooling device is in place.


Secondary Outcome Measures :
  1. Composite of performance outcomes [ Time Frame: Assessed over 36 hours of treatment. ]
    Secondary performance outcomes include the feasibility of inducing, maintaining, and rewarming patients from targeted temperature management using the Esophageal Cooling Device. Specifically, cooling rate, rewarming rate, and the percent of time during the goal- temperature maintenance period within 1°C of goal temperature (typically 33°C, but with some centers using anywhere from 32°C to 36°C) will be measured.

  2. Composite of safety outcomes [ Time Frame: Assessed over 36 hours of treatment and up to 30 days of follow-up. ]
    Secondary safety outcomes include evaluation of adverse events including the following: cardiac arrhythmias, severe bradycardia, myocardial infarction/re-infarction, dysphagia, odynophagia, aspiration pneumonia, non-aspiration pneumonia, reflux, esophageal injury, and esophagitis.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient population will consist of 15 patients suffering from traumatic brain injury, in whom the treating clinician has determined that targeted temperature management will be initiated.

Exclusion Criteria:

  • Patients with known esophageal deformity or evidence of esophageal trauma (for example, known esophageal varices, cirrhosis, history of esophagectomy, previous swallowing disorders, achalasia, etc.).
  • Patients with known ingestion of acidic or caustic poisons within the prior 24 hours.
  • Patients with less than 40 kg of body mass.
  • Patients known to be pregnant.
  • Terminal disease or "do not resuscitate order" that could lead to early-onset therapeutic withdrawal.
  • Unstable hemodynamic conditions that could lead to multi-organ failure and early-onset death.
  • Pre-existing severe conductive disorder requiring pacing.

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): NCT02420639


Locations
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Ukraine
Dnipropetrivsk State Medical Academy based on Dnipropetrivsk Regional Clinical Hospital
Dnipropetrovs'k, Ukraine
Sponsors and Collaborators
Advanced Cooling Therapy, LLC
Dnipropetrovsk State Medical Academy
Investigators
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Principal Investigator: Oleksandr Tsarev, MD Dnipropetrivsk State Medical Academy based on Dnipropetrivsk Regional Clinical Hospital n.a. Mechnikov, Department of Anesthesiology and Intencive Care Medicine, 14 Octoberskay sq., Dnipropetrivsk 49600, Ukraine

Publications:

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Responsible Party: Advanced Cooling Therapy, LLC
ClinicalTrials.gov Identifier: NCT02420639     History of Changes
Other Study ID Numbers: ACT TBI-01
First Posted: April 20, 2015    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries