Traumatic Brain Injury
Conditions
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).
Interventions
DEVICEEsophageal Cooling Device (ECD), manufactured by Advanced Cooling Therapy, Inc.
Use of the Esophageal Cooling Device for control of patient temperature.
Sponsors
Dnipropetrovsk State Medical Academy
Advanced Cooling Therapy, Inc., d/b/a Attune Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Initiation of Temperature Management | 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
| Measure | Time frame | Description |
|---|---|---|
| Composite of Performance Outcomes | 36 hours | 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. |
| Composite of Safety Outcomes | 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. |
Countries
Ukraine
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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).
Esophageal Cooling Device (ECD), manufactured by Advanced Cooling Therapy, Inc.: Use of the Esophageal Cooling Device for control of patient temperature. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Intervention | — |
|---|---|---|
| Age, Continuous | 42 years STANDARD_DEVIATION 16 | — |
| BMI | 25.3 kg/m^2 STANDARD_DEVIATION 2.3 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Ukraine | 12 participants | — |
| Sex: Female, Male Female | 1 Participants | — |
| Sex: Female, Male Male | 11 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 1 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
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.
Time frame: 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Time to Initiation of Temperature Management | 5.83 hours | Standard Deviation 5 |
Secondary
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.
Time frame: 36 hours
Secondary
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.
Time frame: Assessed over 36 hours of treatment and up to 30 days of follow-up.