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The Turbine-based CO2 Insufflator Pediatric Feasibility Study

RecruitingNAAges any - 18 YearsAllErasmus Medical Center
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In plain words

What the trial is, and whether it could suit you

A novel CO2 insufflator, the Turbine-based insufflator, has been developed to improve minimally invasive surgery. Turbine technology permits accurate pressure control resulting in an intra-abdominal volume that is dynamically adapted to ventilation. In addition, oscillometric measurements are performed to measure the abdominal compliance of the patient. This feasibility trial primarly aims to evaluate the technologic feasibility during pediatric laparoscopic surgery. Secondary outcomes are pressure stability, comparison of intra-abdominal pressure stability between the standard CO2 insufflator and the Turbine-based insufflator, and comparison of ventiliation pressures between these insufflators.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Weight โ‰ฅ 10 kilograms; * Laparoscopic procedure; * Intraperitoneal procedure; * Written informed consent. Exclusion Criteria: * Inability to use the study-specific trocar during the procedure (surgeon's assessment); * The expected time for abdominal insufflation is less than 20 minutes; * Conversion to open surgery within 10 minutes after study measurements; * Pregnancy.
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What it tests

  • Turbine-based insufflator
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Where

1 site
Erasmus MC, University Medical Center Rotterdam
Rotterdam, Netherlands
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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