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Study of a New Clinical Device for Reducing Body Core Temperature

NCT01996982 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2019-07-29

Study results available
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Summary

This is a descriptive, nonrandomized, noninvasive, single-group, single-center pilot study of a Core Cooling System (CCS) device for reducing core body temperature in ICU patients at University Medical Center Brackenridge (UMCB) and Seton Medical Center Austin (SMCA). The proposed research on human subjects will provide data that will be used to improve a specialized human heat transfer technique/device. By stimulating specialized blood vessels (arteriovenous anastomoses) AVAs in the palm of the hand, it is possible to greatly increase local blood flow and thus greatly increase the potential for effective heat transfer between the environment and body.

The hypothesis of this trial is that the Core Cooling System (CCS) will prove to be a practical, safe, and effective method to raise or lower body temperature in critically ill patients.

Conditions

  • Hypothermia

Interventions

DEVICE

CCS Device

Core Cooling System Device

Sponsors & Collaborators

  • University of Texas at Austin

    collaborator OTHER

  • Seton Healthcare Family

    lead OTHER

Principal Investigators

  • Alex B Valadka, MD, FACS · Seton Healthcare Family

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United States

Study Locations

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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 NCT01996982 on ClinicalTrials.gov