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
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