Physician Study of Device Effectiveness

Easier Elevation. Reduced Risk of Trauma.
Impacted Fetal Head Release Device
Physician Study of Device Effectiveness
The following data is from the initial case-control study of C-Snorkel effectiveness by Barrier, et al.*
Controls were screened and matched using an objective, standardized method. The study was
carried out at in an academic center in the US. In the study physicians were asked to rate the overall
effectiveness of the device compared to their previous experience in performing cesarean delivery
of a well-impacted fetal head. Using
RESPONSES GROUPED BY STATION
a 7-point scale where 1= SignifiC-Snorkel Feature
cantly Worse and 7= SignificanAll
Mid
Low
tly Improved; most believed the
Delivering
n=38
n=30
n=8
C-Snorkel “moderately improved”
Physicians
the experience. According to the
6.2
6.3
5.9
Average
results the device improved the
Moderately
Moderately
Moderately
Response
Improved
Improved
Improved
experience at low-stations(+2 and+3)
and mid-stations (0 to+1).
DETAIL OF OUTCOME BY STATION
C-Snorkel Feature
C-Snorkel Used
Device Not Used
Station
0
+1
+2
0
+1
+2
Total Patients
6
11
5
24
17
8
Extensions
0
0
3
9
5
2
Vaginal Assistant
0
0
1
6
5
1
* Follow complete Instructions
for Use when using this device.
STATISTICAL COMPARISON OF PATIENT OUTCOMES
C-Snorkel Feature
*Barrier BF, Allison JL,
Andelin CO, Drobnis EZ. The simple
device prevents hysterotomy
extensions during cesarean delivery
for failed second stage of labor.
Gynecologic and Obstetric
Investigation, in press.
Hysterotomy
Extension
Vaginal
Assistant
Position
w/C-Snorkel
Device Not Used
Controls
Fisher’s
Exact Test
Mid (0 to +1)
0 (0%)
14 (34%)
P<0.01
Low (+2 to +3)
3 (50%)
2 (25%)
P=0.58
Mid (0 to +1)
0 (0%)
11 (27%)
P=0.02
Low (+2 to +3)
2 (33%)
1(13%)
P=0.54
Cases
Clinical Innovations, LLC
747 West 4170 South
Murray, UT 84123 USA
www.clinicalinnovations.com
Tel. 801-268-8200
Fax 801-266-7373
Made in USA
Latex Free DEHP Free