Thermogard™ Efficacy Trial

The purpose of this study is to determine if the Thermogard™ central venous catheter can prevent hypothermia (defined as a core body temperature less then 36.0 °C) in severely burned patients who are undergoing surgery for debridement and grafting in the setting of reduced ambient room temperature.

Study Overview

• Status: Terminated
• Conditions: Burns; Hypothermia
• Intervention / Treatment: Device: Thermogard™; Device: Standard central venous catheter

Detailed Description

Hypothermia in the severely burned has been shown to disrupt coagulation, impair myocardial function, weaken the host immune response, delay wound healing and increase mortality.

Current methods available for preventing and reversing hypothermia include administering heated, humidified oxygen, infusing warmed intravenous fluids centrally, performing peritoneal dialysis with warmed fluid, undergoing extracorporeal blood warming with partial bypass, and markedly increasing the ambient room temperature. These methods are either limited in their effectiveness or are impractical and potentially dangerous. Furthermore, the practice of markedly increasing the ambient room temperature creates a hostile work environment for health care providers which may impact patient care.

The FDA has classified the Alsius Thermogard™ heat exchange catheter as a Class II devices under 21 C.F.R §§ 870.5900. It is used in various clinical applications for cooling patients but it has not been FDA-approved for use in warming burn patients. The Thermogard™ is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controller unit, a heat exchanger unit, and roller pump. It supplies temperature controlled sterile saline to the indwelling catheter that is placed percutaneously in the patient. The catheter can be placed in the femoral vein (larger catheter with three heat exchange balloons) or the subclavian or jugular vein (smaller catheter with two heat exchange balloons).

Sterile saline is warmed (to a maximum temperature of 38 °C) in the external device and then pumped through the balloons coaxially mounted on the catheter, enabling direct warming of the blood. The catheter contains a temperature probe enabling a 'closed loop' temperature control system; the temperature is set at the desired level (the range of the device is 28-38°C, which may vary according to the installed software), after which the device warms the patient to this level by increasing or decreasing the temperature of the circulating saline. The core temperature is then maintained at the desired level for as long as the attending physician deems necessary. The catheter also has two ports for central venous access, which can be used to administer medication and/or for blood sampling.

The purpose of this study is to determine if the Thermogard™ central venous catheter can significantly impact the heat stress environment of the operating room by allowing severely burned patients to undergo surgery for debridement and grafting at lower ambient operating room temperatures when compared to control subjects.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult males and non-pregnant females ages 18-70 with greater than 20% TBSA burns requiring excision and grafting and in need of a central venous catheter per ICU admission criteria.
• Patient or patient's surrogate must be able to verbalize understanding and willingness to participate in the study and provide written informed consent

Exclusion Criteria:

• Pregnancy. All females admitted to the burn ICU undergo routine serum hCG to determine pregnancy status. Those found to be pregnant will be excluded from entry into the study
• Burn patients enrolled in recombinant Factor VII study due to the theoretical increased risk for clot formation
• Basic and advanced enlisted trainees
• Age greater than 70 years old due to increased mortality rate among those severely burned
• Conditions which make placement of a central venous catheters a greater than normal risk (vascular anomalies, previous vascular surgery, etc.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; Burn patients with >20% TBSA burns scheduled to undergo debridement and grafting who will have placed the Thermogard™ central venous warming catheter by Alsius	Device: Thermogard™; Those who have a Thermogard™ central venous warming catheter placed prior to surgery; Other Names: Rewarming
Active Comparator: B; Burn patients with >20% TBSA burns scheduled to undergo debridement and grafting who will have placed a central venous catheter as a part of their routine burn management	Device: Standard central venous catheter; Those who have a standard central venous catheter placed prior to surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ambient room temperature	Intraoperative

Secondary Outcome Measures

Outcome Measure	Time Frame
Compare the incidence, duration and severity of hypothermia,	Beginning of surgery to eight hours postoperative
Compare the need for perioperative blood and/or blood product transfusions as a function of the percent total body surface area (TBSA) excised and grafted during surgery	Beginning of surgery to eight hours postoperative
Compare the incidence of foreshortened surgery due to refractory hypothermia defined as a persistent core body temperature less than 35.0 °C.	Intraoperative
Compare the difference between skin/core body temperature and the ambient room temperature of those physicians and associate staff members providing care to burn patients in the operating room	Intraoperative

Collaborators and Investigators

• Sponsor: Brooke Army Medical Center
• Investigators: Principal Investigator: Timothy F. Haley, MD, Brooke Army Medical Center; Study Director: Steven E. Wolf, MD, US Army Institute of Surgical Research

Publications and helpful links

General Publications

• Kurz A, Sessler DI, Lenhardt R. Perioperative normothermia to reduce the incidence of surgical-wound infection and shorten hospitalization. Study of Wound Infection and Temperature Group. N Engl J Med. 1996 May 9;334(19):1209-15. doi: 10.1056/NEJM199605093341901.
• Frank SM, Fleisher LA, Breslow MJ, Higgins MS, Olson KF, Kelly S, Beattie C. Perioperative maintenance of normothermia reduces the incidence of morbid cardiac events. A randomized clinical trial. JAMA. 1997 Apr 9;277(14):1127-34.
• Jurkovich GJ, Greiser WB, Luterman A, Curreri PW. Hypothermia in trauma victims: an ominous predictor of survival. J Trauma. 1987 Sep;27(9):1019-24.
• Robinson S, Katariya K, et al. Perioperative temperature management: Roundtable discussion identifies need to avoid hypothermia. Minutes from the Anesthesia Patient Safety Foundation. 11 June 2005; Louisville, KY
• Doufas AG. Consequences of inadvertent perioperative hypothermia. Best Pract Res Clin Anaesthesiol. 2003 Dec;17(4):535-49. doi: 10.1016/s1521-6896(03)00052-1.
• Weinberg AD. Hypothermia. Ann Emerg Med. 1993 Feb;22(2 Pt 2):370-7. doi: 10.1016/s0196-0644(05)80467-6.
• Gore DC, Beaston J. Infusion of hot crystalloid during operative burn wound debridement. J Trauma. 1997 Jun;42(6):1112-5. doi: 10.1097/00005373-199706000-00022.
• Soung LS, Swank L, Ing TS, Said RA, Goldman JW, Perez J, Geis WP. Treatment of accidental hypothermia with peritoneal dialysis. Can Med Assoc J. 1977 Dec 17;117(12):1415-6. No abstract available.
• Wong PS, Pugsley WB. Partial cardiopulmonary bypass for the treatment of profound accidental hypothermic circulatory collapse. J R Soc Med. 1992 Oct;85(10):640. doi: 10.1177/014107689208501021. No abstract available.
• El-Gamal N, Elkassabany N, Frank SM, Amar R, Khabar HA, El-Rahmany HK, Okasha AS. Age-related thermoregulatory differences in a warm operating room environment (approximately 26 degrees C). Anesth Analg. 2000 Mar;90(3):694-8. doi: 10.1097/00000539-200003000-00034. Erratum In: Anesth Analg. 2017 Sep;125(3):1085.
• Hancock PA, Vasmatzidis I. Effects of heat stress on cognitive performance: the current state of knowledge. Int J Hyperthermia. 2003 May-Jun;19(3):355-72. doi: 10.1080/0265673021000054630.
• Koenders S, Struijs A, et al, Feasibility of an intravenous warming device to rewarm cardiac surgery patients. NJCC 2004;8:34.
• Karabinis A, Mandila C, Koukoulitsios G, Dounis G, Tsoutsos D. Using an intravascular device to reverse refractory burn-associated hypothermia. Anaesth Intensive Care. 2008 Nov;36(6):918-9. No abstract available.
• Willekes T, Naunheim R, Lasater M. A novel method of intravascular temperature modulation to treat severe hypothermia. Emerg Med J. 2006 Oct;23(10):e56. doi: 10.1136/emj.2006.035360.
• Arthurs Z, Cuadrado D, Beekley A, Grathwohl K, Perkins J, Rush R, Sebesta J. The impact of hypothermia on trauma care at the 31st combat support hospital. Am J Surg. 2006 May;191(5):610-4. doi: 10.1016/j.amjsurg.2006.02.010.

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: January 13, 2009
• First Submitted That Met QC Criteria: January 13, 2009
• First Posted (Estimate): January 14, 2009

Study Record Updates

• Last Update Posted (Estimate): July 24, 2013
• Last Update Submitted That Met QC Criteria: July 22, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Hypothermia; Coagulopathy; Severe burns; Warming catheter; Thermogard™
• Additional Relevant MeSH Terms: Body Temperature Changes; Hypothermia
• Other Study ID Numbers: I.2008.030; CIRO 2008235