Turbine-based CO2 Insufflator in Pediatric Laparoscopy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This feasibility trial evaluates a turbine-based CO2 insufflator (TBI) designed to provide precise, dynamically adjusted pressure during pediatric laparoscopic procedures. Secondary goals compare intra-abdominal pressure stability and ventilation pressures against a standard insufflator. The study uses oscillometric measurements to gauge abdominal compliance and explore potential benefits for smaller patients. The primary focus is technologic feasibility and safety in the pediatric surgical setting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Weight ≥ 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.

Where it's running

• Erasmus MC, University Medical Center Rotterdam
  Rotterdam, South Holland, Netherlands Recruiting

Study contacts

• Principal investigator: J. Vlot — Erasmus Medical Center
• Study coordinator: A.I. Jong
• Email: a.i.dejong@erasmusmc.nl
• Phone: +31107037641

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.