- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01017887
Intraperitoneal Carbon Dioxide Concentration Measurement During Standard Laparoscopy With a New Airseal Access Port
September 3, 2013 updated by: David Earle, Baystate Medical Center
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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
Observational
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients undergoing a laparoscopic operation.
Description
Inclusion Criteria:
- all patients undergoing a laparoscopic operation
Exclusion Criteria:
- pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Airseal port for laparoscopic surgery
Airseal access port for laparoscopic surgery with standard ports.
|
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.
Prospective monitoring of CO2 levels during laparoscopic surgery with standard access ports.
|
Standard Laparoscopy ports
Uses standard laparoscopy ports.
|
Prospective monitoring of CO2 levels during laparoscopic surgery with standard access ports.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
percent of intraperitoneal carbon dioxide during surgery
Time Frame: intraoperative - starts at beginning of the operation and ends at the completion of the operation
|
intraperitoneal carbon dioxide measurements intraoperatively
|
intraoperative - starts at beginning of the operation and ends at the completion of the operation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
subcutaneous emphysema
Time Frame: during the patients hospital stay, or the first 5 days postoperatively.
|
during the patients hospital stay, or the first 5 days postoperatively.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David Earle, MD, Baystate Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Anticipated)
October 1, 2013
Study Completion (Anticipated)
October 1, 2013
Study Registration Dates
First Submitted
August 4, 2009
First Submitted That Met QC Criteria
November 20, 2009
First Posted (Estimate)
November 23, 2009
Study Record Updates
Last Update Posted (Estimate)
September 4, 2013
Last Update Submitted That Met QC Criteria
September 3, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- IRB09-107
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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