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Trial record 4 of 4 for:    19535947 [PUBMED-IDS]

Study of a New Clinical Device for Reducing Body Core Temperature

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ClinicalTrials.gov Identifier: NCT01996982
Recruitment Status : Terminated (The Prinicipal Investigator left the organization and decided to close the trial)
First Posted : November 27, 2013
Last Update Posted : April 27, 2017
Sponsor:
Collaborator:
University of Texas at Austin
Information provided by (Responsible Party):
Seton Healthcare Family

Brief 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.


Condition or disease Intervention/treatment Phase
Hypothermia Device: CCS Device Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of a New Clinical Device for Reducing Body Core Temperature
Study Start Date : March 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

Arm Intervention/treatment
Experimental: Device
CCS Device application
Device: CCS Device
Core Cooling System Device




Primary Outcome Measures :
  1. Adverse events from application and use of the Core Cooling System (CCS) device. [ Time Frame: 1 year after the enrollment is closed ]
    1. Assess and capture all adverse events (if any) from application and use of the CCS device.
    2. Also assess CCS device interference with participant's standard of care.


Secondary Outcome Measures :
  1. Number of participant's with adverse events from induction of therapeutic hypothermia (TH). [ Time Frame: 1 year after the enrollment is closed. ]
    Assess and capture all adverse events from induction of TH with CCS device.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Admitted to UMCB ICU
  • Sedated, intubated and or mechanically ventilated
  • At least one core temperature measurement device in place (rectal, bladder, pulmonary artery) as standard of care
  • Medical/surgical condition is stable enough to permit uninterrupted testing and observation for at least 24 hours
  • No medical/surgical procedures are anticipated as necessary or scheduled during testing and observation period that would be affected by this protocol
  • Vital signs and other parameters have been stable for at least 12 hours and there are no imminent indications of instability
  • LAR available and willing to provide informed consent

Exclusion Criteria:

  • Condition is too unstable to permit uninterrupted testing and observation
  • Pregnant and breast feeding patients
  • Patients that might worsen with TH, including coagulopathy (INR>1.5), thrombocytopenia (platelet count <100,000)
  • Patients on antiplatelet therapy other than aspirin
  • Patients on anticoagulants other than prophylactic low molecular weight heparin
  • Patients on pressors to maintain blood pressure
  • Patients with injuries to extremities that could preclude application of cooling mittens or socks to at least three extremities
  • Patients on TH treatment for any other condition

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01996982


Locations
United States, Texas
University Medical Center Brackenridge
Austin, Texas, United States, 78701
Seton Medical Center
Austin, Texas, United States, 78705
Sponsors and Collaborators
Seton Healthcare Family
University of Texas at Austin
Investigators
Principal Investigator: Alex B Valadka, MD, FACS Seton Healthcare Family

Publications:

Responsible Party: Seton Healthcare Family
ClinicalTrials.gov Identifier: NCT01996982     History of Changes
Other Study ID Numbers: CR-13-148
First Posted: November 27, 2013    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Seton Healthcare Family:
Induced therapeutic hypothermia

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms