Tayyab S Diwan, MD1, J-c Verdeja, MD2, Kenneth W Volker, MD3. 1University of Cincinnati, 2South Miami Hospital, 3Centennial Hills Medical Center
OBJECTIVE OF THE DEVICE:
When the laparoscope is removed for cleaning/defogging, it must be cleaned and either a defogging solution applied and/or be warmed before reinsertion. Otherwise fogging will reoccur instantly. Additionally, upon reinsertion the lens is frequently smudged with debris and/or silicone grease from the trocar seals (the latter serves as a lubricant) requiring the scope to be removed and cleaned again which is frustrating to the OR staff. The FloShield® Air System (FloShield) is a single use disposable device that facilitates intra-operative defogging and deflection of debris from the lens of a laparoscope. The advantage of utilizing FloShield is that it significantly reduces the need to remove the laparoscope for cleaning/defogging, therefore minimizing surgical interruptions.
DESCRIPTION OF THE TECHNOLOGY AND METHOD OF USE
FloShield® Air consists of a multi-lumen sheath assembly (device) that mounts over the shaft of the laparoscope. A pre-connected tube set connects the device to the existing CO2 insufflation circuit. To prevent fogging, a small portion of CO2 directed through the FloShield device and across the laparoscope lens, thereby preventing significant accumulation of condensation. Additionally, the continuous flow and velocity of gas across the lens creates a laminar flow or “wind shear,” which serves to help deflect smoke and surgical debris away from the laparoscope lens during surgery.
The primary objective of this study was to compare the number of laparoscope removals for the purpose of lens cleaning during surgery between two products. FloShield® (test) was effective in reducing laparoscope removals for purposes of cleaning as compared to a control method, the Clearify™ Visualization System (D-HELP). Overall, FloShield showed a statistically significant reduction in laparoscope removal in both the ITT and PP populations (56.4% reduction, p = 0.0207) (56.2% reduction, p = 0.0194) when compared to control.
Regardless of the energy type used, FloShield’s performance versus control resulted in statistical significance. FloShield showed a 95% reduction (p = 0.0035) in scope removals when monopolar/bipolar energy was used, and a 51% reduction (p = 0.0482) in surgeries where harmonic energy was used.
Other analyses were done in this study as well. A questionnaire revealed that surgeons consistently rated FloShield higher than control for overall video clarity, consistency of video clarity, and ability to see tissue planes. In addition, the scope was outside the body an average of 2.39 minutes less with FloShield than control which was also statistically significant.
There was no statistical significance in the secondary endpoints (percent of time the laparoscope is outside the body, length of surgery, average time between laparoscope removals).
Overall, FloShield Air significantly reduced the need to remove the laparoscope during surgery for purposes of cleaning/defogging when compared to a commonly used defogging device. The reduction in laparoscope removals with FloShield has the potential to increase OR efficiency through reducing surgical interruptions and improving video clarity. There were no safety issues identified in this study.