The Turbine-based CO2 Insufflator Pediatric Feasibility Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorErasmus Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Weight ≥ 10 kilograms;
Laparoscopic procedure;
Intraperitoneal procedure;
Written informed consent.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Turbine-based insufflator
DeviceUse of the Tubine-based insufflator during surgical procedure.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Pediatric laparoscopyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The number of adverse device events as assessed by observations during the procedure (qualitative measurements)
Observations of researcher and surgeon (number of adverse device events)
Time frame
During surgerySecondary outcomes
1
Assessment of intra-abdominal pressure stability, assessed by the median and interquartile range of the actual measured pressure
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.
Time frame
During surgery2
Registration of events that impair intra-abdominal pressure stability (observationa, qualitative)
Time frame
During surgery3
Comparison of intra-abdominal pressure stability and ventilation pressures between conventional insufflation and turbine-based insufflation by comparing median, minimum, and maximum pressures.
Between turbine-based insufflation and conventional insufflation.
Time frame
During surgery4
Abdominal compliance by performing endoscopic oscillometry in a pediatric population (using insufflation pressure and flow for calculating the abdominal compliance; quantitative measurements)
Intra-abdominal pressure and intra-abdominal flow data recording during surgical procedure.
Time frame
During surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Erasmus Medical Center
Lead sponsor
Politecnico di Milano University
Collaborator
Health∼Holland, Topsector Life Sciences & Health
Collaborator
Spatium Medical B.V.
Collaborator
Source ClinicalTrials.gov