Pneumoperitoneum Management With SurgiQuest AirSeal® at Low vs. Higher Pressure

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

Secondary outcome measures include severity of shoulder pain measured using a VAS scale and
medication use, 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 surgery.

Inclusion Criteria:

1. Pediatric subjects (<21 years of age)

2. > 20 kg in weight;

3. Capable and willing to provide parental Informed Consent and patient Assent;

4. Acceptable candidate for laparoscopic surgery;

Exclusion Criteria:

1. Active cutaneous infection or inflammation;

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

3. Uncontrolled diabetes mellitus

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

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

6. Currently involved in any other investigational clinical Studies;

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

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

9. Extreme morbid obesity (BMI greater than 45 kg/m2)

10. Patients presenting with Ascites