CLINICAL

AHA Recommendations

Donnino MW et al, “Temperature Management After Cardiac Arrest: An Advisory Statement by the Advanced Life Support Task Force of the International Liason Committee on Resuscitation and the American Heart Association Emergency Cardiovascular Care Committee and the Council on Cardiopulmonary, Critical Care, Perioperative, and Resuscitation”, Circulation 2015; 132.

Canadian Recommendations (CAEP, CCCS, CNCCS, CCCTG)

Howes D, Gray SH, Brooks SC, Boyd JG, Djogovic D, Golan E, Green RS, Jacka MJ, Sinuff T, Chaplin T, Smith OM, Owen J, Szulewski A, Murphy L, Irvine S, Jichici D, Muscedere J, “Canadian Guidelines for the Use of Targeted Temperature Management (Therapeutic Hypothermia) After Cardiac Arrest: A joint statement from The Canadian Association of Emergency Physicians (CAEP), the Canadian Critical Care Society (CCCS), Canadian Neurocritical Care Society (CNCCS), and the Canadian Critical Care Trials Group (CCCTG)” Resuscitation (2015), http://dx.doi.org/10.1016/j.resuscitation.2015.07.052.

FDA Cleared Indications for Use

The ThermoSuit is a thermal regulating system Indications for use are:

a. Temperature reduction in patients where clinically indicated, e.g. in hyperthermic patients;

b. Monitoring of patient temperature.

Patient Population

The ThermoSuit System (Size M) is indicated for patients
Greater than 58”(147 cm) and less than 75” (190 cm) in height
And less than 26” (66 cm) in width

References

References with content related to the LRS ThermoSuit® System are denoted with the following: TSS

References with content related to liquid contact cooling are denoted with the following: LCC

References with content related to timing of cooling are denoted with the following: TC

Schock RB,Kupas D,and Freedman RJ, “Letter to the Editor: Therapeutic Cooling Needs to be Faster and Deeper to Improve Outcomes!” Therapeutic Hypothermia and Temperature Management, Published Online:28 Jan 2022 https://doi.org/10.1089/ther.2021.0037

Freedman, RJ and Schock, RB, “Rapid Therapeutic Hypothermia: Saving Lives and Decreasing Healthcare Costs”, Cardiovascular Summit, American College of Cardiology 2022 (https://www.acc.org/education-and-meetings/meetings/meeting-items/2021/07/09/11/55/2022-cv-summit)

Tan PMS, “Evaluation of Various Cooling Systems After Exercise-Induced Hyperthermia,” Journal of Athletic Training 2017; 52(2): 108-116

Schock Robert B., Janata Andreas, Peacock W. Frank, Deal Nathan S., Kalra Sarathi, and Sterz Fritz, “Time to Cooling Is Associated with Resuscitation Outcomes”, Therapeutic Hypothermia and Temperature Management. October 2016, ahead of print. doi:10.1089/ther.2016.0026. TC

Kaneko T, Kasoka S, Nakahara T,  “Effectiveness of lower target temperature therapeutic hypothermia in post-cardiac arrest syndrome patients with a resuscitation interval of ≤30 min”, Journal of Intensive Care (2015); 3:28.

Sendelbach S, Hearst MO, Johnson PJ, Unger BT, Mooney MR, “Effects of Variation in Temperature Management on Cerebral Performance Category Scores in Patients Who Received Therapeutic Hypothermia Post Cardiac Arrest”, Resuscitation 83 (2012), 829-834 TC

Mooney MR, Unger BT, Boland LL et al, “Therapeutic Hypothermia After Out-of-Hospital Cardiac Arrest: Evaluation of a Regional System to Increase Access to Cooling”, Circulation 2011, 124:206-214. TC

Howes D, Ohley W, Dorian P, Klock JC, Freedman R, Schock R, Krizanac D, Holzer M, “Rapid Induction of Therapeutic Hypothermia using Convective-Immersion Surface Cooling: Safety, Efficacy, and Outcomes”, Resuscitation 2010 Vol. 81, no .4, 388-392. TSS

Janata A, Weihs W, Bayegan K, Schratter A, Holzer M, Behringer W, Schock RB, Losert UM, Springler G, Schmidt P, Sterz P, “Therapeutic hypothermia with a novel surface cooling device improves neurologic outcome after prolonged cardiac arrest in swine“, Crit Care Med 2008 Vol. 36, no. 3, 895-902. TSS

Shraetter, A., Weihs, W., Holzer, M., Janata, A., Behringer, W., Losert, U., Ohley W., Schock, R., Sterz, F., ‘External cardiac defibrillation during wet surface cooling in pigs, American Journal of Emergency Medicine (2007) 25, 420-424. TSS

Plattner, Olga MD; Kurz, Andrea MD; Sessler, Daniel I. MD; Ikeda, Takehiko MD; Christensen, Richard BS; Marder, Danielle BS; Clough, David MD,, ” Efficacy of Intraoperative Cooling Methods”, Anesthesiology. 87(5):1089-1095, November 1997. LCC

Proulx, C. I., M. B. Ducharme, and G. P. Kenny, “Effect of water temperature on cooling efficiency during hyperthermia in humans”, J Appl Physiol 94(4):1317-1323, 2003. LCC

McDermott BP, Casa DJ, Ganio MS, Lopez RM, Yeargin SW, Armstrong LE, Maresh CM., “Acute Whole-Body Cooling for Exercise-Induced Hyperthermia: A Systematic Review”, J Athl Train. 2009 Jan-Feb; 44(1): 84-93. LCC

Smith JE, “Cooling methods used in the treatment of exertional heat illness”, Br J Sports Med 2005; 39:503-507. LCC

Holzer M, “Devices for rapid induction of hypothermia”, European Journal of Anesthesiology 2008; 25; (Suppl 42): 31-38. TC

Wolff B, Machill K, Schumacher D, Schulzki I, Werner D, “Early achievement of mild therapeutic hypothermia and the neurologic outcome after cardiac arrest”, International Journal of Cardiology 2009. TC

Polderman K and Herold I, “Therapeutic hypothermia and controlled normothermia In the intensive care unit: Practical considerations, side effects, and cooling methods”, Crit Care Med 2009. TC

Shao Z-H, Chang W-T, Ki, Chan KC, Wojcik KR, Hsu C-W, Li C-Q, Li J, Anderson T, Qin Y, Becker LB, Hamann KJ, Vanden Hoek TL “Hypothermia-induced cardioprotection using extended ischemia and early reperfusion cooling”, Am J Physiol Heart Circ Physiol 292, H1995-H2003, 2007 TC

Markgraf CG, Clifton GL, Moody MR, “Treatment window for hypothermia in brain injury”, J Neurosurg. 2001 Dec; 1995(6):979-83. TC