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

NCT ID: NCT02420639

Last Updated: 2021-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2017-11-30

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).

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).

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

Use of the Esophageal Cooling Device for control of patient temperature.

Interventions

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

Use of the Esophageal Cooling Device for control of patient temperature.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dnipropetrovsk State Medical Academy

OTHER

Sponsor Role: collaborator

Advanced Cooling Therapy, Inc., d/b/a Attune Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oleksandr Tsarev, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Dnipropetrivsk State Medical Academy based on Dnipropetrivsk Regional Clinical Hospital

Dnipro, , Ukraine

Countries

Ukraine

References

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.

Reference Type: BACKGROUND

PMID: 22972067 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24742169 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24004918 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18539227 (View on PubMed)

Badjatia N. Hyperthermia and fever control in brain injury. Crit Care Med. 2009 Jul;37(7 Suppl):S250-7. doi: 10.1097/CCM.0b013e3181aa5e8d.

Reference Type: BACKGROUND

PMID: 19535955 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23827887 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25660954 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ACT TBI-01

Identifier Type: -

Identifier Source: org_study_id