ZOLL Thermogard XP IVTM Physician Manual - Manual (Page 19)

ZOLL IVTM™ System Physicians' Manual
600248-001 Rev 3 18
Table 7. Complication Rates Compared to SCVIR Data
Specific Major Complications for Image-guided Central Venous Access
SCVIR
Expected
Complication
Rate(%)
SCVIR
Proposed
Threshold
Rate(%)
Observed Complication Rate
(%) in Cool Line/ CoolGard
Clinical Trial
Subclavian and jugular
approaches
Cool Line Control
Pneumothorax 1-2 3 0.9 3.3
Hemothorax 1 2 1.9 0
Hematoma 1 2 0 0
Perforation 0.5-1 2 0 0
Air embolism 1 2 0 0
Wound dehiscence 1 2 0 0
Procedure-induced sepsis 1 2 0 0`
Thrombosis 4 8 3.3 7.8
None of the procedure related adverse events are unexpectedly high. There is no
indication that the Cool Line has unacceptable performance as a central line.
There were 4 patients in whom a CL-2085B could not be inserted. There were 2
patients for whom a CL-2295A could not be inserted but in whom success was
achieved with a CL-2085B.
The first pass and overall success rates for CL-2085B are presented in the table
below for the three insertion sites, Femoral, Jugular and Subclavian. Insertions were
considered a failure if the failure was not due to an operator error (e.g. contamination
of first catheter prior to insertion and then successfully implanting the second catheter
on its first attempt would be counted as a successful insertion even though two
catheters were used).
Table 8. Cool Line Catheter Insertion Success
n pts 1st Pass Success n,% Success n,%
Femoral 20 14 70% 20 100%
Jugular 22 19 86% 22 100%
Subclavian 111 107 96% 108 96%
Total 153 140 92% 150 98%