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

This study has been withdrawn prior to enrollment.
(Unable to recruit any subjects)
Sponsor:
Information provided by (Responsible Party):
David Earle, Baystate Medical Center
ClinicalTrials.gov Identifier:
NCT01017887
First received: August 4, 2009
Last updated: September 3, 2013
Last verified: September 2013

August 4, 2009
September 3, 2013
October 2011
October 2013   (final data collection date for primary outcome measure)
percent of intraperitoneal carbon dioxide during surgery [ Time Frame: intraoperative - starts at beginning of the operation and ends at the completion of the operation ] [ Designated as safety issue: No ]
intraperitoneal carbon dioxide measurements intraoperatively
percent of intraperitoneal carbon dioxide [ Time Frame: intraoperative - starts at beginning of the operation and ends at the completion of the operation ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01017887 on ClinicalTrials.gov Archive Site
subcutaneous emphysema [ Time Frame: during the patients hospital stay, or the first 5 days postoperatively. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Intraperitoneal Carbon Dioxide Concentration Measurement During Standard Laparoscopy With a New Airseal Access Port
SurgiQuest AirSeal CO2 Gas Quality

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

patients undergoing a laparoscopic operation.

Laparoscopic Carbon Dioxide Measurement
  • Device: Airseal access port for laparoscopic surgery
    The investigators will utilize this access port that is already approved by the FDA for it's intended use in laparoscopic surgery. The investigators are simply measuring the percentage of carbon dioxide in the peritoneal cavity.
  • Device: Standard Laparoscopy ports
    Prospective monitoring of CO2 levels during laparoscopic surgery with standard access ports.
  • Airseal port for laparoscopic surgery
    Airseal access port for laparoscopic surgery with standard ports.
    Interventions:
    • Device: Airseal access port for laparoscopic surgery
    • Device: Standard Laparoscopy ports
  • Standard Laparoscopy ports
    Uses standard laparoscopy ports.
    Intervention: Device: Standard Laparoscopy ports
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
October 2013
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • all patients undergoing a laparoscopic operation

Exclusion Criteria:

  • pregnancy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01017887
IRB09-107
No
David Earle, Baystate Medical Center
Baystate Medical Center
Not Provided
Principal Investigator: David Earle, MD Baystate Medical Center
Baystate Medical Center
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP