Erasmus MC, University Medical Center Rotterdam
Rotterdam, South Holland, 3015 GD, Netherlands
Location status: Recruiting
Recruiting
NCT Number: NCT07715968
The Turbine-based CO2 Insufflator Pediatric Feasibility Study
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 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 turbine-based insufflator, and comparison of ventiliation pressures between these insufflators.
Recruiting
Interested in participating?
Request InfoKey information
Age range
Up to 18 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
A new CO2 insufflator, the turbine-based insufflator (TBI), has been developed with an insufflation technique that enables highly accurate pressure control that is dynamically adapted to ventilation. It is hypothesized that this novel insufflation technique provides more stable abdominal pressures than conventional insufflators and reduces the need for high ventilation pressures. The pediatric population can benefit greatly from this new insufflation technique, as small changes in pressure settings and stabilization of the surgical field already have a relatively large impact.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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 than 20 minutes;
- Conversion to open surgery within 10 minutes after study measurements;
- Pregnancy.
Treatment and study plan
Turbine-based insufflator
DeviceUse of the tubine-based insufflator during surgical procedure.
Primary outcomes
-
The number of adverse device events as assessed by observations during the procedure (qualitative measurements)
Time frame: During surgery
Observations of researcher and surgeon (number of adverse device events)
Secondary outcomes
-
Assessment of intra-abdominal pressure stability, assessed by the median and interquartile range of the actual measured pressure
Time frame: During surgery
Recording the intra-abdominal pressure with a pressure line during the surgical procedure. Assessment of the difference between the actual measured pressure and the target pressure. Stability is defined as the median pressure with the interquartile range.
-
Registration of events that impair intra-abdominal pressure stability (observationa, qualitative)
Time frame: During surgery
-
Comparison of intra-abdominal pressure stability and ventilation pressures between conventional insufflation and turbine-based insufflation by comparing median, minimum, and maximum pressures.
Time frame: During surgery
Between turbine-based insufflation and conventional insufflation.
-
Abdominal compliance by performing endoscopic oscillometry in a pediatric population (using insufflation pressure and flow for calculaing the abodminal compliance; quantitative measurements)
Time frame: During surgery
Intra-abdominal pressure and intra-abdominal flow data recording during surgical procedure.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Erasmus Medical Center
Other
Collaborators
- Health∼Holland, Topsector Life Sciences & Health
- Politecnico di Milano University
- Spatium Medical B.V.
Registry information
Official study title
The Use of the Turbine-based CO2 Insufflator in Pediatric Laparoscopic Surgery - a Feasibility Trial
Acronym: TuBa
Important dates
- Study start
- 2026
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Jul 21, 2026
- Registry last updated
- Jul 21, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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