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

Status:Not yet recruiting
Therapuetic Areas:Orthopedics / Podiatry
Age Range:Any - 21
Start Date:January 2020
End Date:November 2027
Contact:Maryan Mathis, MS, BSN

Use our guide to learn which trials are right for you!

A Single Center, Prospective, Randomized, Controlled Study To Evaluate Physician Preference Related To The Use Of The Surgiquest Airseal® Insufflation System (AIS) At Low Vs. Higher Pressure For The Management Of Pneumoperitoneum

A prospective, randomized, controlled single-center clinical Study designed to evaluate
Physician Preference related to the use of the SurgiQuest AirSeal® Insufflation System (AIS)
at low vs. higher pressures for the Management of pneumoperitoneum. Subjects will be
randomized in a 1:1 treatment device to control ratio into one of two (2) different study

1. AIS with an insufflation pressure target of 9mmHg ±1mmHg; or

2. AIS with an insufflation pressure target of 15mmHg ±1mmHg.

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

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
We found this trial at
Akron, OH
Click here to add this to my saved trials