A Comparative Study Between AirSeal, an Integrated Insufflation System, and Conventional Insufflation

Study Overview
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Brief Summary
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Renal cancer has traditionally been treated by surgical removal of the tumor, as the tumors are resistant to chemotherapy and radiation. The traditional treatment, where the entire kidney and tumor were removed through an abdominal incision, may now have more long term problems than the actual cancer. As a result, less invasive techniques have been developed such as laparoscopic surgery where the abdomen is inflated with carbon dioxide (i.e. via an insufflation system) and the surgery performed with special instruments through small ports, known as trocars. Rapid advances in minimally invasive surgical techniques demand ongoing technological improvement. Conventional insufflators and trocars allow for laparoscopic surgery to occur, however the system does not account for pressure changes within the abdomen when instruments are inserted or removed. The AirSeal® System consisting of an insufflation, filtration, and recirculation system (AirSeal® IFS), a triple lumen filtered tube set, and a valve free trocar (AirSeal® Access Port) has been designed to create and maintain the pressure barrier throughout the procedure. The objective of this study is to collect comparative physiological, pulmonary compliance and surgical utility data for both the AirSeal® System and conventional insufflators and trocars in a controlled population undergoing laparoscopic/robotic renal or peri-renal procedures. Subjects enrolled in this study will have their procedure performed using either the AirSeal® System or a conventional insufflator and trocars. Both systems have been cleared for use by the FDA's 510(k) process and are currently employed in clinical practice, including at University of California, Irvine Medical Center. We hypothesize that with the use of the AirSeal® System, laparoscopic efficiencies and outcomes will be significantly greater than with the conventional insufflator and trocars system.

Detailed Description
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Rapid advances in minimally invasive surgical techniques demand ongoing technological improvement. The benefits of laparoscopic surgery to patient comfort and recovery have been made with procedures such as the cholecystectomy and gastric bypass. 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. The AirSeal® System has applications in abdominal minimally invasive surgical procedures to establish a path of entry for laparoscopic instruments. The insufflation and recirculation system (AirSeal® IFS) is reusable and the AirSeal® Access Port and triple lumen filtered tube set are designed as single patient use devices. The 1st generation AirSeal® System received FDA 510(k) clearance in 2007 and the current system received FDA 510(k) Clearance in May 2011. Since that time, the AirSeal™ system has been used routinely in centers throughout the United States and has been observed by surgeons and anesthesia teams to provide a more gentle, stable, and consistent pneumoperitoneum. Initial evidence of this has reported in the literature1. Kavoussi and colleagues state; We have found that patients had blunted end-tidal carbon dioxide (CO2) levels and CO2 elimination rates compared with the CO2 elimination rates observed in studies evaluating transperitoneal laparoscopy using the conventional trocar. To determine if a difference truly exists, CO2 elimination rates must be prospectively analyzed in a head to head comparison between valve-less and conventional trocars. This study is designed to compare the physiological impact and pulmonary compliance of patients undergoing laparoscopic/robotic renal or peri-renal surgery with and without the AirSeal® System. 1 A new Valve-Less Trocar for Urology Laparoscopy: Initial Evaluation. Journal of Endourology 2009;23: 1535-39

Official Title
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A Comparative Study of the Physiological Response, Between AirSeal, an Integrated Insufflation and Access System, and Conventional Insufflation and Trocars

Conditions
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Renal Cell Carcinoma

Intervention / Treatment
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* Device: AirSeal® System-Interventional
* Device: Conventional Insufflator and Trocar


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Competent adult (18 years of age and older) males and females. Persons undergoing laparoscopic/robotic renal or peri-renal procedures. Exclusion criteria: Under age 18 Unable to provide informed consent Have a history of ascites History of transplant kidney Solitary kidney (one kidney) Uncontrolled Diabetes (HbA1c > 8) Pregnancy (as noted by standard of care history and physical) Women who are breast-feeding History of narcotic abuse or chronic pain Emergency Surgery Person's participating in any other research

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Conventional Insufflation and Trocars<br>Subjects enrolled in this study arm will have their procedure performed using either the conventional insufflator and trocars. This system have been cleared for use by the FDA's 510 (k)process and are currently employed in clinical practice, including at UC Irvine Medical Center. | Device: Conventional Insufflator and Trocar<br>* Conventional insufflator and trocars are used in standard procedures and will serve as the base for comparison of the study device (AirSeal® System).<br>|
| Active Comparator: AirSeal® System-Interventional<br>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). | Device: AirSeal® System-Interventional<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AirSeal Reduction in the Variance of Intra-abdominal Pressure | Our primary aim is to show reduction in the variance of intra-abdominal pressure throughout the operative procedure when using the AirSeal device compared to a conventional insufflator. Based on preliminary data, we assume pressures maintained at a mean of 15 through out surgery for both devices and a variance of 3.6 with the conventional insufflator. | Day 1 (Day of Procedure) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Cardiac Output With the AirSeal Device. | Assuming cardiac output of approximately 5.0 L/min with the conventional device, we will have 96% power to detect as significant an improvement in cardiac output to 5.5 L/min using a two-group Satterwaite t-test and assuming variance of 0.25. Cardiac out put is defined by the volume of blood pumped by the heart in a given amount of time. | Day 1 (Day of Procedure) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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trocars, renal cell carcinoma, minimally invasive procedures, robotic nephrectomy, laparoscopic nephrectomy, pneumoperitoneum, AirSeal® IFS