ZOLL Thermogard XP IVTM User Manual

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IVTMTM 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.

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Physician Manual Rev. 3

Trademarks

Alsius, CoolGard, CoolGard 3000, Thermogard XP, IVTM, Cool Line, Solex, Quattro, and Icy are registered trademarks of 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 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.

Telephone: +1-408-541-2140

Facsimile: +1-408-541-1030

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

Central Set-Point 7

Peripheral Responses 8

Summation of Peripheral and Central Sensory Signals 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

Controlled Rate 10

FEVER (FVR) 11

Warming (Warm) 11

The Patient Environment 11

Cool Line Catheter 13

Fever Management – The Standard of Care 13

Standard Methods of Fever Reduction 13

Fever Reduction Clinical Study 14

Clinical Study Summary 14

Objective: 14

Materials and Methods: 14

Results: 14

Clinical Study Results in Detail 15

Significant Reduction in Fever Burden 15

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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

Rewarming Post-Cardiac Surgery 22

Neurosurgery 22

Operative Hypothermia 22

Rewarming 23

Catheter Selection 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

Infection 28

Specific Operational Issues 30

Stop the Pump 30

Air Bubble Detector 30

Fluid Loss Detector 31

To check the integrity of the catheter: 31 To check the integrity of the tubing set: 31

Cool Line Catheter – Two Functions 32

Seven Days – Cool Line Catheter Only 32 “Dead Head” Pressure 32

Water and Propylene Glycol 32

Dual Temperature Probes 33 Single Use/Service Life 33

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Check the Pinwheel 33

References 34

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Introduction

Scope

This manual applies to the ZOLL Intravascular Temperature Management (IVTM™) System which consists of both the CoolGard 3000® and the Thermogard XP® 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. Please consult the Operation Manual for the IVTM System and the Instructions For Use for the IVTM Catheters prior to use.

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Cool Line Catheter - Indications for Use

The IVTM System and Cool Line® Catheter is indicated for use in fever reduction, as an adjunct to other antipyretic therapy, in patients with cerebral infarction and intracerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated.

Warning – Fever Reduction

The safety of this device has not been demonstrated for fever reduction in patients presenting with subarachnoid hemorrhage or primary traumatic brain injury. The safety and effectiveness of this device was examined in a randomized controlled trial of 296 patients. The mortality results 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 hemorrhage).

Mortality by Diagnosis (ITT)

		Cool Line				Control
	n		N	%	n	N	%	p-value*
CI	3		16	18.8	3	14	21.4	0.74
ICH	8		33	24.2	7	27	25.9	1.00
PTBI	10		44	22.7	4	38	10.5	0.24
SAH	13		61	21.3	7	63	11.1	0.15

*Fischer’s exact test

For more details on the results of this study please refer below to the section on Clinical Experience.

Icy , Quattro & Solex Catheters - Indications for Use

The IVTM System, using either the Icy®, Quattro®or Solex ® Catheters, is indicated for use:

•in cardiac surgery patients to achieve and or maintain normothermia during surgery and recovery/intensive care, and,

•to induce maintain and reverse mild hypothermia in neuro surgery patients in surgery and recovery/intensive care.

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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 37o ± 1oC.

Normal Control of Body Temperature1

The body temperature is a reflection of the equilibrium state between the body and its environment. Within an environmental range of approximately 13oC to 54oC, a normal unclothed human can maintain a core body temperature somewhere between 36oC and 37.9oC [1].

Heat is generated within the body via chemical and physical processes of the body. The physical processes include both bodily activity and cellular respiration. Heat is a byproduct of cellular respiration–most of this heat is generated in skeletal muscle and, to a lesser extent, in brown fat and in the liver. Seventy five percent or more of total energy input is released back to the environment directly as heat (depending upon the level of physical activity). Shivering is a specific example of muscular activity to produce heat.

Heat loss is via conduction to materials in direct contact with the 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 to the surface layer of water where it then drives a phase change–the movement of unsaturated air accelerates the process); the latter being specifically variable in response to body temperature. Typical sources of human heat loss in a room at normal temperatures are shown in the table below [1].

Table 1. Human Heat Loss by Source.

Source	Percent
Radiation	60%
Evaporation	22%
Conduction to objects	3%
Convection/conduction to air	15%

In general, humans have a central control mechanism that seeks to maintain body temperature in reference to a set-point. This set-point can be varied by both internal and external mechanisms. For a given set-point, the body will act to maintain a temperature (see following). For example, with a fever, attempts to withdraw heat will be resisted until the set-point for that febrile body temperature is reset.

Central Set-Point

Temperature regulation is centered in the hypothalamus. The preoptic area of the hypothalamus seems to serve as the thermostatic center for the body.

1 Unless otherwise stated, the general references used in this chapter are Guyton and Hall, 2001 [1] and Schonbaum and Lomax, 1991 [2].

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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. The response of the sensors is dominated by their response to cold.

Summation of Peripheral and Central Sensory Signals

The posterior hypothalamus receives signals from both the peripheral temperature sensors and from the preoptic area of the hypothalamus. The signals are integrated and central control signals are sent to the skin to modify sweating, vasodilatation, and piloerection.

The dorsomedial portion of the posterior hypothalamus is normally inhibited by the preoptic portion and excited by cutaneous cold sensors. Excitation of this area due to cold leads to stimulation of muscle cells via the lateral columns. This action increases the resting tone of the muscle, which triggers the stretch reflex. The resulting contraction pattern is an oscillation between opposing muscle groups with no purposeful movement.

Increased Body Temperature

The body’s temperature increases either from increased heat generation (cellular respiration or shivering), or reductions in skin losses. Increased cellular 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 to no more than 10–15% of the basal metabolic energy output. It is the result of the uncoupling of oxidative phosphorylation in response to circulating norepinephrine and epinephrine.

In a cold environment, significant increases in thyroxine level and therefore metabolic drive, do occur. However this is a long-term adaptation and is of little consequence in discussing the short-term regulation of body temperature.

For the intubated and sedated patient:

•Shivering is pharmacologically damped or lost.

•Central control, driven by the summation of peripheral and central sensory input, is reduced or lost.

•Disturbed hypothalamic function can directly reset the temperature setpoint.

Thermal Regulation and Disease States

Fever is a response to either endogenous or exogenous pyrogens, or direct effects upon the hypothalamic temperature control centers.

Pyrogens

Endogenous pyrogens are families of polypeptides (e.g., interleukin 1) that are produced by macrophages, monocytes, and other white cells. They are mediators of inflammation. They act centrally upon the hypothalamus to modify thermoregulation. The typical fever response shows an initial abrupt rise in core temperature to a peak (acute phase response) with a more gradual decay to normothermia. Endogenous pyrogens do not appear to have other than central effects upon thermoregulation.

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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. The hypothalamus is exposed to cerebrospinal fluid as well as to blood, so it can be subject to the action of CSF-borne pyrogens [2].

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This Product in its Environment

Introduction

The first law of thermodynamics can only be applied after defining the system. For our purposes the system consists of three elements:

1.The patient:

•Is intubated and sedated.

•Is warmer than the environment and therefore will lose heat to the environment.

•Will lose more heat to the environment if wet than if dry.

2.The environment. This is typically controlled by air conditioning that is far more powerful than the patient (i.e., it will react to overcome any heat the patient adds to the environment). Within this discussion, outside of the performance of the IVTM System , the single most significant effect upon the patient is the rate of heat loss to the environment.

NOTE: When comparing catheter performance, only results obtained from controlled in-vitro methods should be used. Heat exchange to the environment within the clinical setting can be significant and variable depending upon environmental conditions 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 System and the saline in the coil of the Start-Up Kit.

•Between the saline in the catheter balloons and the blood of the patient.

The IVTM System responds to both the difference between the patient’s temperature and the set-point and to the rate of change of the patient’s temperature. The system will add or remove heat to maintain the patient at the set-point.

Treatment Algorithms

There are four treatment algorithms in RUN: “Max Power”, “Controlled Rate”, "Warming", and “FEVER”.

Max Power (MAX)

In this treatment option, the IVTM System seeks to make the patient’s temperature the same as the selected target temperature. It will keep the saline pump operating unless the patient’s temperature “inverts”. This occurs whenever:

A. Bath Temperature > Patient Temperature > Target Temperature, OR

B. Bath Temperature < Patient Temperature < Target Temperature.

Controlled Rate

In this treatment option, the IVTM System will attempt to move the patient’s temperature to the target temperature at the programmed rate of heat exchange (°C

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	/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.
		NOTE: Controlled Rate
		NOTE: Controlled Rate
		Controlled rate operates in both warming and cooling modes.

	FEVER (FVR)
	In this treatment option, the IVTM System		will starting cooling the patient once the
	patient temperature is above the target temperature. It does this by keeping the bath
	at its coldest permissible temperature and then operating the saline pump whenever
	the patient’s temperature moves above the target temperature. Maximum cooling
	power is always applied as with Max Power.
		WARNING! “Lo” patient temperature alarm limit with “FEVER”
		The IVTM System will NOT heat the patient when the “FEVER” treatment option
		has been selected. The “Lo” patient temperature alarm limit ensures that an
		alarm occurs should the patient stop regulating his/her own body temperature.
		Such patients will cool to room temperature. This can occur when the patient
		dies or becomes comatose.
		INVESTIGATE ALL PATIENT TEMPERATURE ALARMS.
	Warming (Warm)
	In this treatment option, 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 the saline pump whenever
	the patient’s temperature moves below the target temperature. Maximum warming
	power is always applied as with Max Power.
		WARNING! “Hi” patient temperature alarm limit with
		“Warming”
		The IVTM System will NOT cool the patient when the “Warming” treatment option
		has been selected. The “Hi” patient temperature alarm limit ensures that an
		alarm occurs should the patient become febrile.
		INVESTIGATE ALL PATIENT TEMPERATURE ALARMS.

The Patient Environment

The patient is in equilibrium with his/her environment. The average human generates between 75 and 100 watts of energy. Much of this is spent in simply keeping the body hotter than the environment–heat is lost through convection/conduction to the air and materials that touch the body (sweat facilitates this loss), heat is lost through respiration, and heat is lost via infrared radiation.

The rate of heat loss, under normal conditions, is primarily affected by the ratio of the surface area of the patient’s body to his/her weight. Think of the body as a stack of cubes: some on the surface that can lose heat to the environment and others inside that have no direct contact. Only the outside surfaces of the cubes that are the

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