The purpose of this study is to compare carbon dioxide (CO2) absorption during gynecologic laparoscopy using the AirSeal® valveless trocar system versus standard insufflation trocars at intra-abdominal pressures of 10 and 15 mmHg. The investigators hypothesize that with the AirSeal® valveless trocar system, gynecologic laparoscopy can be performed at a lower intra-abdominal pressure with a possible resultant decrease in CO2 absorption, while maintaining adequate visualization of the operative field for safe completion of surgery.
Three main factors affect patients' cardiopulmonary status during gynecologic laparoscopy: 1) degree of Trendelenburg tilt (25 - 30°), 2) carbon dioxide (CO2) absorption and 3) increased intra-abdominal pressure (10 -20 mmHg). Slight modifications to any or all of these three factors can lead to a significant decrease in morbidity. The AirSeal® valveless trocar system reduces CO2 absorption when compared to standard trocars during renal laparoscopy. Also, use of this trocar system provides a more stable intra-abdominal pressure when compared to standard trocars, a feature that could possibly allow for laparoscopic surgery to be performed at lower intra-abdominal pressures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
132
The AirSeal® trocar is a valveless trocar that has been designed to replace the "trap door" and silicone valve of standard trocars with a curtain of forced CO2 gas. With the AirSeal® trocar, escaping gas is collected at the proximal end of the trocar, filtered, and redirected into the peritoneal cavity to maintain the pressure differential. The result is an invisible barrier that instantaneously responds to changes in intra-abdominal pressure, either by allowing more CO2 inflow with pressure drops or by serving as a pressure relief valve during pressure spikes.
A standard insufflation trocar delivers CO2 into the abdominal cavity to create workspace and uses either a "trap door" or silicone valve to prevent the egress of CO2 during laparoscopy in order to maintain intra-abdominal pressures. The standard trocars are not equipped to respond to changes in the intra-abdominal pressures in order to trigger an increase or decrease in the flow rate of CO2 gas.
Columbia University Medical Center
New York, New York, United States
Average Carbon Dioxide (CO2) Absorption During Gynecologic Laparoscopy Using the AirSeal® Versus Standard Trocars at Intra-abdominal Pressures of 10 mmHg
This outcome is measured by calculating the CO2 elimination rate. CO2 absorption rates were obtained at 15 and 60 minutes during each case and an average value was calculated per case. In cases \< 60 minutes, the CO2 absorption rate at 15 minutes will be used.
Time frame: 15 minutes & 60 minutes from surgery start time
Median Surgeon Questionnaire Score When Using AirSeal® Versus Standard Trocars
Surgeon Questionnaire (0 "not adequate" -10 "optimal") is designed to evaluate the visualization of operative field by surgeon during colpotomy.
Time frame: At the end of surgery (approximately 1 hour)
Number of Participants With no Problem When Using AirSeal® Versus Standard Trocars
Anesthesia Questionnaire (0 "no problem" - 2 "very problematic) is designed to evaluate the the level of difficulty in maintaining adequate end-tidal CO2 (etCO2).
Time frame: At the end of surgery (approximately 1 hour)
Median VAS Pain Score When Using AirSeal® Versus Standard Trocars
Visual Analog Scale (VAS) Pain Score (0 "no pain" - 10 "worst pain") is designed to evaluate the level of pain post-surgery.
Time frame: 4 to 6 hours, and 12 to 23 hours following surgery
Average Carbon Dioxide (CO2) Absorption During Gynecologic Laparoscopy Using the AirSeal® Versus Standard Trocars at Intra-abdominal Pressures of 15 mmHg
This outcome is measured by calculating the CO2 elimination rate.
Time frame: 15 minutes & 60 minutes from surgery start time
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.