Study of a New Clinical Device for Reducing Body Core Temperature

NCT01996982 | Terminated Results

• 1 other identifier: CR-13-148
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

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.

Conditions

Hypothermia

Keywords

Induced therapeutic hypothermia

Outcome Measures

Primary Outcomes (1)

• Adverse Events From Application and Use of the Core Cooling System (CCS) Device.

  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.

  1 year after the enrollment is closed

Secondary Outcomes (1)

• Number of Participant's With Adverse Events From Induction of Therapeutic Hypothermia (TH).

  1 year after the enrollment is closed.

Study Arms (1)

Device

EXPERIMENTAL

CCS Device application

Device: CCS Device

Interventions

CCS Device DEVICE

Core Cooling System Device

Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seton Healthcare Family: lead
• University of Texas at Austin: collaborator

Study Sites (2)

University Medical Center Brackenridge

Austin, Texas, 78701, United States

Location

Seton Medical Center

Austin, Texas, 78705, United States

Location

Related Publications (9)

• Grahn DA, Cao VH, Heller HC. Heat extraction through the palm of one hand improves aerobic exercise endurance in a hot environment. J Appl Physiol (1985). 2005 Sep;99(3):972-8. doi: 10.1152/japplphysiol.00093.2005. Epub 2005 May 5.

  PMID: 15879169 BACKGROUND

• Grahn D, Brock-Utne JG, Watenpaugh DE, Heller HC. Recovery from mild hypothermia can be accelerated by mechanically distending blood vessels in the hand. J Appl Physiol (1985). 1998 Nov;85(5):1643-8. doi: 10.1152/jappl.1998.85.5.1643.

  PMID: 9804564 BACKGROUND

• Hales JR, Fawcett AA, Bennett JW, Needham AD. Thermal control of blood flow through capillaries and arteriovenous anastomoses in skin of sheep. Pflugers Arch. 1978 Dec 15;378(1):55-63. doi: 10.1007/BF00581958.

  PMID: 569825 BACKGROUND

• SHERMAN JL Jr. NORMAL ARTERIOVENOUS ANASTOMOSES. Medicine (Baltimore). 1963 Jul;42:247-67. doi: 10.1097/00005792-196307000-00001. No abstract available.

  PMID: 14046752 BACKGROUND

• Krogstad AL, Elam M, Karlsson T, Wallin BG. Arteriovenous anastomoses and the thermoregulatory shift between cutaneous vasoconstrictor and vasodilator reflexes. J Auton Nerv Syst. 1995 Jun 25;53(2-3):215-22. doi: 10.1016/0165-1838(94)00178-m.

  PMID: 7560758 BACKGROUND

• Bergersen TK, Eriksen M, Walloe L. Local constriction of arteriovenous anastomoses in the cooled finger. Am J Physiol. 1997 Sep;273(3 Pt 2):R880-6. doi: 10.1152/ajpregu.1997.273.3.R880.

  PMID: 9321863 BACKGROUND

• Wissler EH. A quantitative assessment of skin blood flow in humans. Eur J Appl Physiol. 2008 Sep;104(2):145-57. doi: 10.1007/s00421-008-0697-7. Epub 2008 Feb 27.

  PMID: 18301912 BACKGROUND

• Polderman KH. Mechanisms of action, physiological effects, and complications of hypothermia. Crit Care Med. 2009 Jul;37(7 Suppl):S186-202. doi: 10.1097/CCM.0b013e3181aa5241.

  PMID: 19535947 BACKGROUND

• Venturi ML, Attinger CE, Mesbahi AN, Hess CL, Graw KS. Mechanisms and clinical applications of the vacuum-assisted closure (VAC) Device: a review. Am J Clin Dermatol. 2005;6(3):185-94. doi: 10.2165/00128071-200506030-00005.

  PMID: 15943495 BACKGROUND

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

No data (beyond protocol enrollment number total) are available for this study as the PI has left the institution and no study team member is present. Sincere efforts were made to obtain the data for reporting, however, no data are available.

Results Point of Contact

• Title: Research Enterprise Staff
• Organization: Ascension Seton

ra@seton.org

512-3247991

Study Officials

• Alex B Valadka, MD, FACS

  Seton Healthcare Family

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: November 27, 2013
• Study Start: March 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 29, 2019
• Results First Posted: June 20, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)