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This study has been withdrawn prior to enrollment.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
  Purpose

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.


Condition Intervention
Laparoscopic Carbon Dioxide Measurement
Device: Airseal access port for laparoscopic surgery
Device: Standard Laparoscopy ports

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: SurgiQuest AirSeal CO2 Gas Quality

Resource links provided by NLM:


Further study details as provided by Baystate Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • subcutaneous emphysema [ Time Frame: during the patients hospital stay, or the first 5 days postoperatively. ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: October 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Airseal port for laparoscopic surgery
Airseal access port for laparoscopic surgery with standard ports.
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.
Standard Laparoscopy ports
Uses standard laparoscopy ports.
Device: Standard Laparoscopy ports
Prospective monitoring of CO2 levels during laparoscopic surgery with standard access ports.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients undergoing a laparoscopic operation.

Criteria

Inclusion Criteria:

  • all patients undergoing a laparoscopic operation

Exclusion Criteria:

  • pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01017887

Sponsors and Collaborators
Baystate Medical Center
Investigators
Principal Investigator: David Earle, MD Baystate Medical Center
  More Information

No publications provided

Responsible Party: David Earle, MD, Baystate Medical Center
ClinicalTrials.gov Identifier: NCT01017887     History of Changes
Other Study ID Numbers: IRB09-107
Study First Received: August 4, 2009
Last Updated: September 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Baystate Medical Center:
laparoscopy
airseal
carbon dioxide
insufflation
pneumoperitoneum

ClinicalTrials.gov processed this record on September 16, 2014