Clinical Trial: Study of CO2 Exchange Patterns During Robotic Prostatectomies

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Comparative Study of CO2 Exchange Patterns Between Valve-free Trocar (AirSeal®) Versus Standard Trocar (Endopath®) During Robotic Prostatectomies

Brief Summary: The AirSeal® System will allow for lower CO2 absorption rates than the Xcel® System. Furthermore, lower variance in pneumoperitoneal pressure will allow for less "over-pressure" events and peritoneal stretch, which may reduce postoperative pain.

Detailed Summary: The primary observation to be made is the level of PaCO2 in the arterial blood, specifically when the patient is insufflated and deflated during the surgery. As a result of the consistent pressure that the AirSeal® system maintains, CO2 will be absorbed in lower levels when compared to the standard of care systems in which fluctuations in intra-peritoneum pressure are seen. Therefore, higher pressures will result in higher levels of CO2 exchange in the blood, leading to increased vasodilation and lower pH levels.
Sponsor: OhioHealth

Current Primary Outcome: Intraoperative pneumoperitoneal pressure (mmHg). [ Time Frame: Through Day 1 post-op ]

Compare the maximum intraoperative pneumoperitoneal pressure (mmHg), smoke evacuation quality (categorical), and overall operative times (minutes) between the conventional and valve-less trocar groups.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: OhioHealth

Dates:
Date Received: January 10, 2014
Date Started: August 2016
Date Completion: February 2017
Last Updated: November 3, 2016
Last Verified: October 2016