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

NCT02420639 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-09-02

Study results available
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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

Interventions

DEVICE

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

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

Sponsors & Collaborators

  • Dnipropetrovsk State Medical Academy

    collaborator OTHER

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

    lead INDUSTRY

Principal Investigators

  • 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

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2017-08-31
Completion
2017-11-30

Countries

  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02420639 on ClinicalTrials.gov