ZOLL Thermogard XP IVTM Physician Manual - Manual (Page 15)

ZOLL IVTM™ System Physicians' Manual
600248-001 Rev 3 14
Fever Reduction Clinical Study
The CoolGard
®
(Model 2060) was a predecessor to the CoolGard 3000 (Model
CoolGard 3000). The CoolGard 3000 has been cleared based upon the data
gathered with the CoolGard heat exchange system. The performance of the
CoolGard/Cool Line catheter system was studied as part of a clinical
investigation, entitled:
A Prospective, Randomized, Controlled Multicenter Clinical Study to Evaluate the
Safety and Effectiveness of the CoolGard System with Cool Line
Catheter in
Reducing Fever in Neurointensive Care Unit Patients.
Clinical Study Summary
Objective:
To study the effectiveness of catheter based heat exchange systems in the reduction
of elevated temperatures in critically ill neurological and neurosurgical patients.
Materials and Methods:
This study was a prospective randomized, non-blinded trial in which conventional
treatment of fever with acetaminophen and water cooling blankets (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). To be eligible the patient’s temperature had to exceed
38
o
C on 2 occasions or for >4 hours and they had to require central venous access.
Temperature was recorded hourly for a minimum of 3 and up to 7 days following
randomization. The temperatures were graphed and the area under the fever curve
which exceeded 38.0
o
C was used as an index of fever burden. The efficacy of the
catheter based system was determined by its ability to reduce fever burden in an
intention to treat analysis. The safety of the catheter system was also examined.
Results:
A total of 296 patients were enrolled over 20 months half of which were randomized
to receive conventional fever management and half conventional management and
the catheter based heat exchange system. Of the patients 41% had SAH, 24% TBI,
23% ICH and 13% ischemic stroke. The two fever control groups were matched in
terms of age, body mass index, gender and overall GCS distribution. Fever burden
for the first 72 hours was 7.92 degree hours in the conventional group and 2.87
degree hours in the catheter group demonstrating a 64% reduction in fever burden
with the catheter system. There was no increase in infections or the use of sedatives,
narcotics or antibiotics in the catheter group.