The Turbine-based CO2 Insufflator Pediatric Feasibility Study
Recruiting
N/A
Interventional Study
Laparoscopy
Pneumoperitoneum
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- Up to 18
- Sex
- Any
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 12 (estimated)
- Sponsor
- Erasmus Medical Center · Other
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About This Trial
A novel CO2 insufflator, the turbine-based insufflator, has been developed to improve minimal 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 evalua…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Weight ≥ 10 kilograms (kg);
* 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…