Cool line catheter - indications for use, Warning – fever reduction, Cool line catheter - indications for use 6 – ZOLL Thermogard XP IVTM Physician Manual User Manual
Page 7: Warning – fever reduction 6
ZOLL IVTM™ System
Physicians' Manual
600248-001 Rev 3
6
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.