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
Akron Children's Hospital
Summary
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.
Description
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 evaluat…
Eligibility
- Age range
- Up to 21 years
- Sex
- All
- Healthy volunteers
- No
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 fibr…
Interventions
- DeviceAirSeal® Insufflation System (AIS)
The AirSeal® System consists of an insufflation, filtration, and recirculation system (AirSeal® iFS), a triple lumen filtered tube set, and a valve free trocar (AirSeal® Access Port). The device enables peritoneal access with a novel mechanism to maintain pneumoperitoneum without a mechanical seal. Specifically, the AirSeal® System creates a pressure barrier within the proximal housing of the cannula which acts as an invisible seal to maintain pneumoperitoneum during the course of surgery. It utilizes a re-circulation and filtration control unit (AirSeal® iFS) designed specifically for the AirSeal® Access Port to create and maintain the pressure barrier.
Location
- Children's Hospital Medical Center of AkronAkron, Ohio