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

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

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 Overview

• Status: Completed
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Device: Esophageal Cooling Device (ECD), manufactured by Advanced Cooling Therapy, Inc.

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).

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ukraine
  • Dnipropetrovs'k, Ukraine
    • Dnipropetrivsk State Medical Academy based on Dnipropetrivsk Regional Clinical Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Initiation of Temperature Management	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.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of Performance Outcomes	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.	36 hours
Composite of Safety Outcomes	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.	Assessed over 36 hours of treatment and up to 30 days of follow-up.

Collaborators and Investigators

• Sponsor: Advanced Cooling Therapy, Inc., d/b/a Attune Medical
• Collaborators: Dnipropetrovsk State Medical Academy
• Investigators: 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 and helpful links

General Publications

• Arrich J, Holzer M, Havel C, Mullner M, Herkner H. Hypothermia for neuroprotection in adults after cardiopulmonary resuscitation. Cochrane Database Syst Rev. 2012 Sep 12;(9):CD004128. doi: 10.1002/14651858.CD004128.pub3.
• Crossley S, Reid J, McLatchie R, Hayton J, Clark C, MacDougall M, Andrews PJ. A systematic review of therapeutic hypothermia for adult patients following traumatic brain injury. Crit Care. 2014 Apr 17;18(2):R75. doi: 10.1186/cc13835.
• Andrews PJ, Sinclair LH, Harris B, Baldwin MJ, Battison CG, Rhodes JK, Murray G, De Backer D; Eurotherm3235Trial collaborators. Study of therapeutic hypothermia (32 to 35 degrees C) for intracranial pressure reduction after traumatic brain injury (the Eurotherm3235Trial): outcome of the pilot phase of the trial. Trials. 2013 Sep 3;14:277. doi: 10.1186/1745-6215-14-277.
• Polderman KH. Induced hypothermia and fever control for prevention and treatment of neurological injuries. Lancet. 2008 Jun 7;371(9628):1955-69. doi: 10.1016/S0140-6736(08)60837-5.
• Badjatia N. Hyperthermia and fever control in brain injury. Crit Care Med. 2009 Jul;37(7 Suppl):S250-7. doi: 10.1097/CCM.0b013e3181aa5e8d.
• Kulstad E, Metzger AK, Courtney DM, Rees J, Shanley P, Matsuura T, McKnite S, Lurie K. Induction, maintenance, and reversal of therapeutic hypothermia with an esophageal heat transfer device. Resuscitation. 2013 Nov;84(11):1619-24. doi: 10.1016/j.resuscitation.2013.06.019. Epub 2013 Jul 1.
• Markota A, Kit B, Fluher J, Sinkovic A. Use of an oesophageal heat transfer device in therapeutic hypothermia. Resuscitation. 2015 Apr;89:e1-2. doi: 10.1016/j.resuscitation.2015.01.032. Epub 2015 Feb 7. No abstract available.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: April 13, 2015
• First Submitted That Met QC Criteria: April 15, 2015
• First Posted (Estimate): April 20, 2015

Study Record Updates

• Last Update Posted (Actual): September 2, 2021
• Last Update Submitted That Met QC Criteria: August 9, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: ACT TBI-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No