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临床试验/NCT01017887
NCT01017887撤回不适用

SurgiQuest AirSeal CO2 Gas Quality

Baystate Medical Center0 个研究点开始时间: 2011年10月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
percent of intraperitoneal carbon dioxide during surgery

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • all patients undergoing a laparoscopic operation

排除标准

  • pregnancy

结局指标

主要结局

percent of intraperitoneal carbon dioxide during surgery

时间窗: intraoperative - starts at beginning of the operation and ends at the completion of the operation

intraperitoneal carbon dioxide measurements intraoperatively

次要结局

  • subcutaneous emphysema(during the patients hospital stay, or the first 5 days postoperatively.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Earle

MD

Baystate Medical Center

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