Pneumoperitoneum Management With SurgiQuest AirSeal at Low vs. Higher Pressure ( PRESSURE )

The objective of this study is to evaluate physician preferences related to use of the
SurgiQuest AirSeal Insufflation System (AIS) used at low vs. higher pressures for
maintaining pneumoperitoneum during laparoscopic/robotic surgical procedures.

The study is designed and powered to demonstrate superiority of the AIS used at low
insufflation pressure (9±mmHg ±1mmHg) vs higher pressure (15mmHg ±1mmHg) in relation to a
single key effectiveness measure: Incidence of shoulder pain. Patients will be randomized
1:1 to either AIS with an insufflation pressure target of 9±1mmHg) or to AIS with an
insufflation target pressure of 15±1mmHg.

Secondary outcome measures include severity of shoulder pain measured using a VAS scale and
medication use, procedure time, the number of procedure interruptions, length of hospital
stay, aspects of anesthesia management including end tidal CO2 and the frequency of adverse
events. These outcomes will be evaluated in a controlled population undergoing
laparoscopic/robotic surgery.

Inclusion Criteria:

1. 18 to 80 years of age;

2. Capable and willing to give informed consent;

3. Acceptable candidate for an elective, non-emergent laparoscopic/robotic surgery;

Exclusion Criteria:

1. Advanced refusal of blood transfusion, if necessary;

2. Active systemic or cutaneous infection or inflammation;

3. Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids;

4. Uncontrolled diabetes mellitus

5. Known, significant history of bleeding diathesis, coagulopathy, Von Willebrand's
disease or current platelet count < 100,000 cells/mm3, baseline INR ≥1.8, or
fibrinogen level less than 150 mg/dl (if received a fibrinolytic agent within prior
24 hours);

6. Severe co-existing morbidities having a life expectancy of less than 30 days;

7. Currently involved in any other investigational clinical Studies;

8. Significant anemia with a hemoglobin level less than 10 g/dL or a hematocrit less
than 30%;

9. Renal insufficiency (serum creatinine of > 2.5 mg/dl);

10. Females who are pregnant, planning to become pregnant within 3 months of the
procedure, or lactating;

11. Extreme morbid obesity (BMI greater than 45 kg/m2) or underweight (BMI less than 20
kg/m2);

12. Patients presenting with Ascites -