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

NCT02420639 | Completed Results

• 1 other identifier: ACT TBI-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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).

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Composite of Performance Outcomes

  36 hours

• Composite of Safety Outcomes

  Assessed over 36 hours of treatment and up to 30 days of follow-up.

Study Arms (1)

Intervention

EXPERIMENTAL

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.

Interventions

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

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Advanced Cooling Therapy, Inc., d/b/a Attune Medical: lead
• Dnipropetrovsk State Medical Academy: collaborator

Study Sites (1)

Dnipropetrivsk State Medical Academy based on Dnipropetrivsk Regional Clinical Hospital

Dnipro, Ukraine

Location

Related Publications (7)

• 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.

  PMID: 22972067 BACKGROUND

• 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.

  PMID: 24742169 BACKGROUND

• 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.

  PMID: 24004918 BACKGROUND

• 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.

  PMID: 18539227 BACKGROUND

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

  PMID: 19535955 BACKGROUND

• 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.

  PMID: 23827887 BACKGROUND

• 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.

  PMID: 25660954 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Alexander Tsarev
• Organization: Department of Anesthesiology & Intensive Care Medicine, Dnipropetrovsk Medical Academy

tsarev03@rambler.ru

+38 057 701 52 00

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2015
• First Posted: April 20, 2015
• Study Start: August 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: November 1, 2017
• Last Updated: September 2, 2021
• Results First Posted: September 2, 2021

Record last verified: 2021-07

Locations

UA (1)