Intraperitoneal Carbon Dioxide Concentration Measurement During Standard Laparoscopy With a New Airseal Access Port

Withdrawn

• Conditions: Laparoscopic Carbon Dioxide Measurement
• Interventions: Device: Airseal access port for laparoscopic surgery; Device: Standard Laparoscopy ports

• Registration Number: NCT01017887
• Lead Sponsor: Baystate Medical Center

Brief Summary

The new AirSeal access port for laparoscopic surgery does not use a mechanical valve on the port to maintain gas in the peritoneal cavity. It uses an invisible barrier created by high flow gas jets within the port. The percentage of carbon dioxide, the standard gas used for laparoscopy, during laparoscopic surgery has not been previously measured, but is probably high. The investigators aim to measure the percentage of intraperitoneal carbon dioxide with standard ports and the AirSeal port during a variety of conditions during laparoscopic procedures including suturing and suctioning. The study period will commence at the start of the operation, and be completed upon discharge from the hospital or postoperative day 5, whichever is shorter. All devices are approved for use in humans by the FDA, and are being used for their intended purpose.

Detailed Description

The SurgiQuest AirSeal system is approved by the Food and Drug Administration (FDA) as access port for laparoscopic surgery that utilizes an invisible air curtain rather than a mechanical barrier to maintain pneumoperitoneum. In addition to the cannula, there is special filtration tubing and an air pump that act in concert with an existing CO2 insufflator. The system has been approved for use and purchase at Baystate Medical Center by the value analysis committee. Despite FDA approval and extensive laboratory testing, there is still no human data regarding intraperitoneal CO2 levels under a variety of conditions one would normally experience during a laparoscopic operation. The specific aim of this study is to measure these levels during laparoscopic cases in humans. We hypothesize that there will be no more than minimal alteration of intraperitoneal CO2 levels when using the AirSeal system when compared to the standard laparoscopic system. The follow-up to this is examining evidence of extraperitoneal gas extravasation. This will occur as part of routine post-operative care, but we will be collecting data, that will be de-identified in the post-operative period.

Study Timeline

• Study First Submitted: 2009-08-04
• Study First Submitted QC: 2009-11-20
• Study First Posted: 2009-11-23
• Study Start: 2011-10
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-03
• Last Update Posted: 2013-09-04
• Primary Completion: 2013-10
• Study Completion: 2013-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• all patients undergoing a laparoscopic operation

Exclusion Criteria

• pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Airseal port for laparoscopic surgery	Airseal access port for laparoscopic surgery	Airseal access port for laparoscopic surgery with standard ports.
Airseal port for laparoscopic surgery	Standard Laparoscopy ports	Airseal access port for laparoscopic surgery with standard ports.
Standard Laparoscopy ports	Standard Laparoscopy ports	Uses standard laparoscopy ports.

Primary Outcome Measures

Name	Time	Method
percent of intraperitoneal carbon dioxide during surgery	intraoperative - starts at beginning of the operation and ends at the completion of the operation	intraperitoneal carbon dioxide measurements intraoperatively

Secondary Outcome Measures

Name	Time	Method
subcutaneous emphysema	during the patients hospital stay, or the first 5 days postoperatively.