Laparoscopic Carbon Dioxide MeasurementNCT01017887
Intraperitoneal Carbon Dioxide Concentration Measurement During Standard Laparoscopy With a New Airseal Access Port
An observational study of Laparoscopic Carbon Dioxide Measurement, run by Baystate Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopic Carbon Dioxide Measurement
- What is being tested?
- Airseal access port for laparoscopic surgery and Standard Laparoscopy ports
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Oct 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing a laparoscopic operation.
Who may be able to join
- all patients undergoing a laparoscopic operation
Who cannot join
- pregnancy
About this study
Official title: 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.
Read the 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.
- Conditions
- Laparoscopic Carbon Dioxide Measurement
- Being tested
- Airseal access port for laparoscopic surgery, Standard Laparoscopy ports
- Keywords
- laparoscopy, airseal, carbon dioxide, insufflation, pneumoperitoneum
- Medical subject headings
- Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airseal access port for laparoscopic surgeryDevice
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.
Standard Laparoscopy portsDevice
Prospective monitoring of CO2 levels during laparoscopic surgery with standard access ports.
| Study group | Role | What they receive |
|---|---|---|
| Airseal port for laparoscopic surgery | Airseal access port for laparoscopic surgery with standard ports. Receives: Device: Airseal access port for laparoscopic surgery; Device: Standard Laparoscopy ports | |
| Standard Laparoscopy ports | Uses standard laparoscopy ports. Receives: Device: Standard Laparoscopy ports |
What is being measured
The primary outcome is the main question the study is designed to answer.
percent of intraperitoneal carbon dioxide during surgery
intraperitoneal carbon dioxide measurements intraoperatively
Measured: intraoperative - starts at beginning of the operation and ends at the completion of the operation
Secondary outcomes (1)
subcutaneous emphysema
Measured: during the patients hospital stay, or the first 5 days postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2009 (estimated)
- Study startOct 2011
- Primary completionOct 2013 (estimated)
- Study completionOct 2013 (estimated)
Why it stopped: Unable to recruit any subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Carbon Dioxide MeasurementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baystate Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Earle, Baystate Medical Center
- Investigators
- David Earle, MD, Principal investigator, Baystate Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01017887
- Sponsor's protocol ID
- IRB09-107
- Status last verified
- Sep 2013
- First submitted
- 4 Aug 2009
- Last updated
- 4 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SurgiQuest AirSeal CO2 Gas Quality
- ClinicalTrials.gov ID
- NCT01017887
- Acronym / sponsor ID
- IRB09-107
- Conditions
- Laparoscopic Carbon Dioxide Measurement
- Keywords
- laparoscopy, airseal, carbon dioxide, insufflation, pneumoperitoneum
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Unable to recruit any subjects
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Baystate Medical CenterUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 23 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Airseal port for laparoscopic surgery | – | Device: Airseal access port for laparoscopic surgery, Device: Standard Laparoscopy portsAirseal access port for laparoscopic surgery with standard ports. |
| Standard Laparoscopy ports | – | Device: Standard Laparoscopy portsUses standard laparoscopy ports. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing a laparoscopic operation.
Key inclusion criteria (1 listed)
- all patients undergoing a laparoscopic operation
Key exclusion criteria (1 listed)
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Airseal access port for laparoscopic surgeryThe 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 | Airseal port for laparoscopic surgery |
| Standard Laparoscopy portsProspective monitoring of CO2 levels during laparoscopic surgery with standard access ports. | Device | Airseal port for laparoscopic surgery, Standard Laparoscopy ports |
Primary outcome
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
1 secondary outcome
subcutaneous emphysema
Time frame: during the patients hospital stay, or the first 5 days postoperatively.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Earle, MD principal investigator
Baystate Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Laparoscopic Carbon Dioxide Measurement, run by Baystate Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2013.