The Turbine-based CO2 Insufflator Pediatric Feasibility Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Turbine-based insufflator.
- Who it may be relevant to
- Registry conditions: Laparoscopy, Pneumoperitoneum. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Use of the Turbine-based CO2 Insufflator in Pediatric Laparoscopic Surgery - a Feasibility Trial
Overview
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.
Detailed description
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.
Interventions
- Device Turbine-based insufflator
Use of the tubine-based insufflator during surgical procedure.
Primary outcome measures
- The number of adverse device events as assessed by observations during the procedure (qualitative measurements) [Time frame: During surgery]
Secondary outcome measures (4)
- Assessment of intra-abdominal pressure stability, assessed by the median and interquartile range of the actual measured pressure [Time frame: During surgery]
- 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]
- 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]
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 than 20 minutes;
- Conversion to open surgery within 10 minutes after study measurements;
- Pregnancy.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Netherlands · 1 center
- Erasmus MC, University Medical Center Rotterdam — Rotterdam
Identifiers
NCT: NCT07715968 · NL-010054