ZOLL Thermogard XP IVTM Physician Manual - Manual (Page 18)

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.