N/A
N=12
Prospective, Interventional Study Evaluating the Feasibility and Safety of the Esophageal Cooling Device
Traumatic Brain Injury
Bottom Line
View on ClinicalTrials.gov: NCT02420639 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Time to Initiation of Temperature Management — 5.83 hours
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Esophageal Cooling Device (ECD), manufactured by Advanced Cooling Therapy, Inc. (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Advanced Cooling Therapy, Inc., d/b/a Attune Medical
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Initiation of Temperature Management |
5.83 | — |
| SECONDARY Composite of Performance Outcomes |
— | — |
| SECONDARY Composite of Safety Outcomes |
— | — |
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).
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.
Data sourced from ClinicalTrials.gov (NCT02420639). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.