ZOLL IVTM™ System
Physicians' Manual
600248-001 Rev 3
17
Table 5. Antipyretic Use during Treatment Period
Cool Line
Control
p*
n/N
%
n/N
%
Any antipyretic medication use
94 / 154
61.0
127 / 142
89.4
<0.0001
•
Acetaminophen
87 / 154
56.5
124 / 142
87.3
<0.0001
•
Ibuprofen
16 / 154
10.4
29 / 142
20.4
0.02
•
Aspirin
18 / 154
11.7
12 / 142
8.5
0.44
* Fisher’s exact test
Complications
The following table lists the number of complications reported, by body system, for all
Cool Line and Control cohort patients within the first 30 days. The numbers
presented are the total 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
Control
Body as a whole
15
9
Cardiovascular
26
21
GI
21
19
Hematologic
19
14
Infectious
93
74
Metabolic/Endocrine
24
18
Neurologic
49
52
Other
10
9
Peripheral vascular
15
13
Pulmonary
66
51
Renal
7
4
Total
330
275
The following table summarizes the SCVIR Guidelines for expected rates of success
and complications and the proposed threshold rates at which some form of retraining
or other action is indicated. In terms of complications, the use of the Cool Line is
generally associated with complication rates within SCVIR guidelines.
