Intraperitoneal Carbon Dioxide Concentration Measurement During Standard Laparoscopy With a New Airseal Access Port
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 4, 2009 | ||||
| Last Updated Date | July 25, 2012 | ||||
| Start Date ICMJE | October 2011 | ||||
| Estimated Primary Completion Date | October 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 |
||||
| Original Primary Outcome Measures ICMJE |
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 ] | ||||
| Change History | Complete list of historical versions of study NCT01017887 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
subcutaneous emphysema [ Time Frame: during the patients hospital stay, or the first 5 days postoperatively. ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Intraperitoneal Carbon Dioxide Concentration Measurement During Standard Laparoscopy With a New Airseal Access Port | ||||
| Official Title ICMJE | SurgiQuest AirSeal CO2 Gas Quality | ||||
| 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 Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | patients undergoing a laparoscopic operation. |
||||
| Condition ICMJE | Laparoscopic Carbon Dioxide Measurement | ||||
| Intervention ICMJE |
|
||||
| Study Group/Cohort (s) |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 50 | ||||
| Estimated Completion Date | October 2013 | ||||
| Estimated Primary Completion Date | October 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01017887 | ||||
| Other Study ID Numbers ICMJE | IRB09-107 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | David Earle, Baystate Medical Center | ||||
| Study Sponsor ICMJE | Baystate Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Baystate Medical Center | ||||
| Verification Date | July 2012 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||