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

Starting soon · Not applicable

Conditions studied: Shoulder Pain

In brief

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 arms: 1. AIS with an insufflation pressure target of 9mmHg ±1mmHg; or 2. AIS with an insufflation pressure target of 15mmHg ±1mmHg.

Key facts

Study ID

NCT02837601

Run by

Akron Children's Hospital

People needed

102

Starts

2021-03-01

Expected to finish

2027-11-01

Last updated by the study team

2020-07-13

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pediatric subjects (<21 years of age)
• > 20 kg in weight;
• Capable and willing to provide parental Informed Consent and patient Assent;
• Acceptable candidate for laparoscopic surgery;

You may not qualify if…

• Active cutaneous infection or inflammation;
• Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids;
• Uncontrolled diabetes mellitus
• 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);
• Severe co-existing morbidities having a life expectancy of less than 30 days;
• Currently involved in any other investigational clinical Studies;
• Significant anemia with a hemoglobin level less than 10 g/dL or a hematocrit less than 30%;
• Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating;
• Extreme morbid obesity (BMI greater than 45 kg/m2)
• Patients presenting with Ascites

Where it is running

• Children's Hospital Medical Center of Akron — Akron, Ohio, United States

Full record on ClinicalTrials.gov

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