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

NCT ID: NCT01017887

Last Updated: 2013-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-10-31

Brief Summary

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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

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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

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Laparoscopic Carbon Dioxide Measurement

Keywords

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laparoscopy airseal carbon dioxide insufflation pneumoperitoneum

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Airseal port for laparoscopic surgery

Airseal access port for laparoscopic surgery with standard ports.

Airseal access port for laparoscopic surgery

Intervention Type DEVICE

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 ports

Intervention Type DEVICE

Prospective monitoring of CO2 levels during laparoscopic surgery with standard access ports.

Standard Laparoscopy ports

Uses standard laparoscopy ports.

Standard Laparoscopy ports

Intervention Type DEVICE

Prospective monitoring of CO2 levels during laparoscopic surgery with standard access ports.

Interventions

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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.

Intervention Type DEVICE

Standard Laparoscopy ports

Prospective monitoring of CO2 levels during laparoscopic surgery with standard access ports.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* all patients undergoing a laparoscopic operation

Exclusion Criteria

* pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baystate Medical Center

OTHER

Sponsor Role lead

Responsible Party

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David Earle

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Earle, MD

Role: PRINCIPAL_INVESTIGATOR

Baystate Medical Center

Countries

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United States

Other Identifiers

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IRB09-107

Identifier Type: -

Identifier Source: org_study_id