ZOLL IVTM, Physician'S Manual

Page 1: ...P H Y S I C I A N M A N U A L 600248 001 Rev 3 IVTM TM Intravascular Temperature Management Caution Federal law restricts this device to sale by or on the order of a physician...

Page 2: ...ZOLL Circulation Inc Mallinckrodt is a registered trademark of Mallinckrodt Inc Windows is a registered trademark of Microsoft Corporation Other products and names listed in this document may be trad...

Page 3: ...8 Increased Body Temperature 8 Thermal Regulation and Disease States 8 Pyrogens 8 Cerebral Injury 9 This Product in its Environment 10 Introduction 10 Treatment Algorithms 10 Max Power MAX 10 Control...

Page 4: ...tion 23 Specific Use Effects 25 Cardiac Function 25 Bradycardia 25 Arrhythmia 25 Lung Function 26 Sepsis 26 Infection 26 General Risks of Central Line Usage 27 Caveats to CVC Placement CVC WG 27 Infec...

Page 5: ...ZOLL IVTM System Physicians Manual 600248 001 Rev 3 4 Check the Pinwheel 33 References 34...

Page 6: ...ters It is intended to provide pertinent clinical information to physicians as they use the IVTM System This manual should be read in conjunction with the Operation Manual for the IVTM System It is no...

Page 7: ...s reported in this trial for the four patient cohorts enrolled are presented in the table below CI cerebral infarction ICH intracerebral hemorrhage PTBI primary traumatic brain injury SAH subarachnoid...

Page 8: ...he body via convection to the air and via infrared emissions We use clothing to help minimize this heat loss Respiration and sweating are specific evaporative convective mechanisms heat is conducted t...

Page 9: ...r respiration at rest is possible by two mechanisms chemical thermogenesis and thyroxine mediated increases in the metabolic rate Chemical thermogenesis in adult humans who lack brown fat is limited t...

Page 10: ...Injury Sustained changes in the thermoregulatory set point are observed with irritation or compression tumor of the hypothalamus In addition intra cerebral release of endogenous pyrogens cerebral infl...

Page 11: ...nditions and the degree to which the patient is able to maintain his her body temperature 3 There are two heat transfers that occur in the IVTM System Between the fluid in the cold well of the IVTM Sy...

Page 12: ...the IVTM System will start warming the patient once the patient temperature is below the target temperature It does this by keeping the bath at its warmest permissible temperature and then operating t...

Page 13: ...return the patient to a normal temperature For a given patient the stronger the endogenous drive to heat production the longer it will take to cool that patient Larger patients will take longer to coo...

Page 14: ...f antipyretic drug therapy using acetaminophen or ibuprofen and external physical cooling Physical cooling includes surface cooling with water or air filled cooling blankets ice packs nasogastric or r...

Page 15: ...were included in the trial subarachnoid hemorrhage SAH intracerebral hemorrhage ICH ischemic infarction CI and traumatic brain injury TBI To be eligible the patient s temperature had to exceed 38 o C...

Page 16: ...0 15 Fischer s exact test Clinical Study Results in Detail Significant Reduction in Fever Burden The table below Reduction in Fever Burden provides the results of the study in terms of its primary end...

Page 17: ...ooling Devices Cool Line Control Reduction p One or more topical cooling device n N 26 154 16 9 67 142 47 2 64 0 0001 Cooling Blanket use n N 25 154 16 2 59 142 41 6 61 0 0001 Other device use n N 7 1...

Page 18: ...otal number of reported adverse events by category and then total overall A patient may have had none one or many adverse events reported in the course of the study Table 6 Complications Cool Line Con...

Page 19: ...ine has unacceptable performance as a central line There were 4 patients in whom a CL 2085B could not be inserted There were 2 patients for whom a CL 2295A could not be inserted but in whom success wa...

Page 20: ...lure mode would be automatically detected and brought to your attention 2 Begin the standard regimen for the investigation of fever In very light patients or in the elderly fever response may be respe...

Page 21: ...view of this history record will show the time at which the fever was initiated a rise in temperature to the trigger threshold The IVTM System history record will also display the cooling bath tempera...

Page 22: ...duce rebound hyperthermia Stevens cit also found approximately 40 of the cardiopulmonary bypass patients they observed reached hyperthermia four hours or more after arrival in the ICU To avoid this co...

Page 23: ...still leave the temperature fluctuating around a desired target Villamaria et al 24 reported in a randomized controlled trial that both forced air warming devices and more conventional warm blankets...

Page 24: ...sons similar to those described for cardiac surgery with the added problem of not having the efficient warming provided by the cardiac bypass pump 41 Shivering is associated with an undesirable increa...

Page 25: ...neration e g through shivering or adrenergic drive and have impaired peripheral vascular responses i e they are rendered essentially poikilothermic by the anesthetic Under these conditions these cathe...

Page 26: ...nophasic action potential As a result Bjornstad et al 11 showed a corresponding decrease in the fibrillation threshold during electrophysiological testing Similar work has been done by Mortensen et al...

Page 27: ...fficient time for organisms introduced during surgery to have reached a pathological mass However it should be remembered that the IVTM System can mask fever Infections could predate the surgical proc...

Page 28: ...ntral venous catheterization must be performed by trained personnel well versed in anatomical landmarks safe technique and potential complications Users in training must be closely supervised by quali...

Page 29: ...ines for the Prevention of Intravascular Catheter Related Infections 43 The recommended preventive strategies with the strongest supportive evidence are Education and training of healthcare providers...

Page 30: ...no more frequently than at 72 hour intervals Replace tubing used to administer blood products or lipid emulsions within 24 hours of initiating the infusion No recommendation for the hang time of intr...

Page 31: ...op under normal operating conditions 1 Temperature inversion The IVTM System will deactivate the pump whenever one of the following states occurs to prevent unwated heat transfer from to the patient C...

Page 32: ...the alarm has been triggered i e in the worst case 400ml of the 500ml fluid in the system can enter the patient The cooling circuit is a closed loop system usually fluid loss alarms indicate a breach...

Page 33: ...inflow and outflow lumens of the catheter together The catheter may then be used as you would any central line Dead Head Pressure The IVTM System relies upon fluid being pumped to and from the patient...

Page 34: ...owly dislodged the temperature sensor will indicate a temperature that moves gradually from the bladder temperature to the temperature of the bed in this example let us say 32 C The system would sense...

Page 35: ...Disease Control Hospital Infection Control Practices Advisory Committee AJIC Am J Infect Control 1996 24 262 93 Available WWW http www cdc gov ncidod hip iv iv htm 10 Chinyanga HM Chapter 9 in Schonba...

Page 36: ...charge Using Conventional Cardiac Surgical Techniques Ann Thoracic Surg 1999 67 363 70 26 Westaby S Pillai R Parry A O Regan D Giannopoulos N Grebenik K Sinclair M Fisher A Does modern cardiac surgery...

Page 37: ...ruya H Sakaki T High dose amrinone is required to accelerate rewarming from deliberate mild intraoperative hypothermia for neurosurgical procedures Anesthesiology 2002 Jul 97 1 116 23 41 Bilotta F Pie...