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

NCT01017887 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2013-09-04

No results posted yet for this study

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.

Conditions

  • Laparoscopic Carbon Dioxide Measurement

Interventions

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.

Sponsors & Collaborators

  • Baystate Medical Center

    lead OTHER

Principal Investigators

  • David Earle, MD · Baystate Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-10-31
Completion
2013-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01017887 on ClinicalTrials.gov