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

Not Applicable

Completed

Conditions: Renal Cell Carcinoma

Interventions: Device: AirSeal® System-Interventional
Device: Conventional Insufflator and Trocar

Registration Number: NCT02075658

Lead Sponsor: University of California, Irvine

Brief Summary: 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: 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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 60

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

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AirSeal® System-Interventional	AirSeal® System-Interventional	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).
Conventional Insufflation and Trocars	Conventional Insufflator and Trocar	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.

Primary Outcome Measures

Name	Time	Method
AirSeal Reduction in the Variance of Intra-abdominal Pressure	Day 1 (Day of Procedure)	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.

Secondary Outcome Measures

Name	Time	Method
Improvement in Cardiac Output With the AirSeal Device.	Day 1 (Day of Procedure)	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.