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Summary of Contents for ZOLL IVTM
- Page 1 IVTM Intravascular Temperature Management P H Y S I C I A N M A N U A L Caution: Federal law restricts this device to sale by or on the order of a physician. 600248-001 Rev. 3...
- Page 2 Windows is a registered trademark of Microsoft Corporation. Other products and names listed in this document may be trademarked by their owners and no representation is made by ZOLL Circulation, Inc. as to rights thereto. ZOLL Circulation, Inc 650 Almanor Avenue Sunnyvale, California U.S.A.
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Page 3: Table Of Contents
ZOLL IVTM™ System Physicians' Manual Contents Introduction 5 Scope 5 Cool Line Catheter - Indications for Use 6 Warning – Fever Reduction 6 Icy, Quattro and SolexCatheters - Indications for Use 6 Thermoregulation 7 Normal Control of Body Temperature 7... - Page 4 ZOLL IVTM™ System Physicians' Manual Complications 17 Specific Use Effects 19 Obvious Fever 19 Masked Fever vs. Steady State 19 In Summary 20 Icy, Quattro & Solex Catheters 21 Cardiac Surgery 21 Afterdrop 21 Fast-Track Recovery After Cardiac Surgery 21...
- Page 5 ZOLL IVTM™ System Physicians' Manual Check the Pinwheel 33 References 34 600248-001 Rev 3...
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Page 6: Introduction
Consoles and IVTM Catheters. 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 not intended to provide sufficient information to the untrained user to understand the safe operation of the IVTM System. -
Page 7: Cool Line Catheter - Indications For Use
For more details on the results of this study please refer below to the section on Clinical Experience. Icy , Quattro & Solex Catheters - Indications for ® ® ® The IVTM System, using either the Icy , Quattro or Solex Catheters, is indicated for use: •... -
Page 8: Thermoregulation
ZOLL IVTM™ System Physicians' Manual Thermoregulation Human beings are mammals: as such their physiology operates to set and maintain body temperature within a narrow band about a set-point, nominally 37 ± 1 Normal Control of Body Temperature The body temperature is a reflection of the equilibrium state between the body and its environment. -
Page 9: Peripheral Responses
ZOLL IVTM™ System Physicians' Manual Peripheral Responses The skin carries sensory receptors to both cold and heat; although, the cold sensors are ten times more numerous. These cutaneous temperature sensors serve as a strong stimulus to shivering and serve to increase or decrease both sweating and vasodilatation. -
Page 10: Cerebral Injury
ZOLL IVTM™ System Physicians' Manual Exogenous pyrogens are polypeptides of origin external to endogenous pyrogens but of similar action. Cerebral 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 inflammation) can have the same effect. -
Page 11: This Product In Its Environment
3. There are two heat transfers that occur in the IVTM System: • Between the fluid in the cold well of the IVTM System and the saline in the coil of the Start-Up Kit. •... -
Page 12: Fever (Fvr)
ZOLL IVTM™ System Physicians' Manual /hr). When the patient reaches the target temperature, the IVTM System will revert to the MAX treatment option i.e. it will attempt to make the patient’s temperature the same as the selected target temperature. ... - Page 13 When the IVTM System is active, heat is removed from the patient. In a febrile patient, the amount of excess heat is the product of the temperature increase and the thermal mass of the patient, unless the patient has as yet untapped reserves for heat generation.
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Page 14: Cool Line Catheter
ZOLL IVTM™ System Physicians' Manual Cool Line Catheter Fever Management – The Standard of Care Fever management has become a standard of care in the neuro-ICU. According to American Heart Association guidelines established for the management of patients with acute ischemic stroke and spontaneous intracerebral hemorrhage, body temper- ature should be maintained at a normal level [3][4]. -
Page 15: Fever Reduction Clinical Study
(conventional group) (standardized across centers) was compared to conventional treatment plus a catheter based heat exchange system (ZOLL Circulation, Inc., Sunnyvale, CA) (catheter group). Four patient populations were included in the trial: subarachnoid hemorrhage (SAH), intracerebral hemorrhage (ICH), ischemic infarction (CI) and traumatic brain injury (TBI). -
Page 16: Clinical Study Results In Detail
There was an highly significant reduction in the fever burden when comparing the use of the IVTM System with the standard methods of fever management. Table 3. Fever Burden – ITT Data Set... - Page 17 ZOLL IVTM™ System Physicians' Manual Cool Line Patients (Mean Temperature ± SD) 38.5 37.5 36.5 Hours Control Patients (Mean Temperature ± SD) 38.5 37.5 36.5 Hours The reduction in fever burden was accompanied by a reduction in the use of adjunctive cooling means as presented in the tables below.
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Page 18: Complications
ZOLL IVTM™ System Physicians' Manual Table 5. Antipyretic Use during Treatment Period Cool Line Control Any antipyretic medication use 94 / 154 61.0 127 / 142 89.4 <0.0001 • 87 / 154 56.5 124 / 142 87.3 <0.0001 Acetaminophen •... - Page 19 ZOLL IVTM™ System Physicians' Manual Table 7. Complication Rates Compared to SCVIR Data Specific Major Complications for Image-guided Central Venous Access SCVIR SCVIR Observed Complication Rate Expected Proposed (%) in Cool Line/ CoolGard Complication Threshold Clinical Trial Rate(%) Rate(%) Subclavian and jugular...
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Page 20: Specific Use Effects
1-2 hours. Restart the system as clinically indicated. With the IVTM System, there is a clear indicator of the activity of the system on the right hand edge of the display. The red/blue meter indicates whether the IVTM System is heating (red) or cooling (blue). -
Page 21: In Summary
System history record will also display the cooling bath temperature over time. In Summary The IVTM System is a heat exchange unit. If the IVTM System is cooling, fever is present. Normal antisepsis regimens should be initiated. 600248-001 Rev 3... -
Page 22: Icy, Quattro & Solex Catheters
ZOLL IVTM™ System Physicians' Manual Icy, Quattro & Solex Catheters Cardiac Surgery Afterdrop Evidence that general hypothermia is of benefit to patients undergoing cardiopulmonary bypass (CPB) has existed since the 1940’s. Not withstanding the development of warm cardioplegia and beating heart techniques, hypothermic CPB remain a standard method used in open-chest cardiac surgery. -
Page 23: Rewarming Post-Cardiac Surgery
ZOLL IVTM™ System Physicians' Manual cooperative, be hemodynamically stable and warm, is not bleeding, and has adequate respiratory function” [22]. The maintenance of normothermia is one of many homeostatic functions that must return. In focused trials it has been shown... -
Page 24: Rewarming
In this application , the IVTM System can be used with four catheters of similar concept but varying size. The Icy catheter is suitable for femoral vein placement without a sheath for up to 4 days. - Page 25 ZOLL IVTM™ System Physicians' Manual Table 9. Catheter Characteristics Catheter Effective Length Infusion Lumen Nominal Power (cooling / heating) 38 cm Proximal, Middle and 140 / 35 W Guidewire (Distal) lumen Quattro 45 cm Proximal, Middle and 180 / 50 W...
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Page 26: Specific Use Effects
There exists a specific risk with any system that relies upon cardiac output, such as the IVTM catheters, for heat exchange. In the event that the catheter system is used in patients that are moderately to severely hypothermic (i.e. below 32°C) it is possible that fibrillation will occur and be irreversible until the heart is warmed. -
Page 27: Lung Function
Infection In this indication, the use of IVTM catheters is intended only for the short period during and post-procedure. Standard asceptic techniques should be followed, in accordance with the Instructions for Use, during insertion. Standard management practices for insertion sites of central lines should be followed for IVTM Catheters. -
Page 28: General Risks Of Central Line Usage
Physicians' Manual General Risks of Central Line Usage The IVTM catheter functions as a central line. As with any central line, the risks of usage relate to the insertion technique, the materials and design of the catheter, and to the state of the patient. The IVTM System and Cool Line Catheter is indicated for... -
Page 29: Infection
ZOLL IVTM™ System Physicians' Manual Infection Catheter Related Bloodstream Infection (CR-BSI) are of concern with any catheter. There is a significantly increased risk of CR-BSI [42] associated with: • Inexperience of the operator and nurse-to-patient ratio in the intensive care unit, •... - Page 30 Given the above, the following points are worth noting about IVTM heat exchange catheters: As with any central line, the primary method for the prevention of CR-BSI with IVTM catheters is to employ a thorough asceptic technique during insertion and with handling of the insertion site and catheter blood path components..
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Page 31: Specific Operational Issues
Stop the Pump The IVTM System is designed so that internal failure modes that pose a threat to the patient will cause the system to stop the pump and sound an audible alarm. This is a safe mode of operation because heat exchange will rapidly cease if there is no flow through the catheter. -
Page 32: Fluid Loss Detector
ALWAYS CHECK FOR FLUID LOSS WITH AN AIR BUBBLE ALARM. It is recommended that the bags of saline solution used to prime and run the IVTM System tubing system be limited in volume to 500 ml or less. In the event of a fluid... -
Page 33: Cool Line Catheter - Two Functions
Usually the inflow lumen has an operating pressure that is almost the same as that in the tubing at the pump and the pressure then drops along the length of the IVTM catheter so that the return pressure is low. -
Page 34: Dual Temperature Probes
The IVTM System features dual temperature probes. One probe, the sensing probe, is typically placed in the bladder and is used to control the IVTM System’s action. The other probe, the backup probe, is typically placed in the rectum and acts as a fail-safe mechanism. - Page 35 ZOLL IVTM™ System Physicians' Manual References Guyton RM & Hall JE. Textbook of medical physiology (10 ed.). New York: WB Saunders 2001. Schonbaum E & Lomax P. (eds). Thermoregulation: pathology, pharmacology, and therapy. New York: Pergamon Press 1991. McGowan JE, Rose RC, Jacobs NF et al. Fever in hospitalized patients. Am J Med 1987;82:580.
- Page 36 ZOLL IVTM™ System Physicians' Manual cardiopulmonary bypass and postoperative radiant heat supply. Acta Anaesthesiol Scand 1987 Aug;31(6):543-9. [19] Keller E, Hegner T, Gasser S, Yonekawa Y and Imhof HG. Heat Exchange Catheters: A New Method to Induce and Maintain Hypothermia. Cleveland Clinic Neurocritical Care 2001.
- Page 37 ZOLL IVTM™ System Physicians' Manual [36] Katsura K, Minamisawa H, Ekholm A. Changes of labile metabolites during anoxia in moderately hypo- and hyperthermic rats: correlation to membrane fluxes of K+. Brain Research 1992; 590: 6-12. [37] Iwata T, Inoue S, Kawaguchi M, Takahashi M, Sakamoto T, Kitaguchi K, Furuya H, Sakaki T.
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