Laparoscopy, Pneumoperitoneum
Conditions
Keywords
Pneumoperitoneum, Device development, Insufflator, Laparoscopy
Brief summary
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.
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
Use of the Tubine-based insufflator during surgical procedure.
Sponsors
Erasmus Medical Center
Politecnico di Milano University
Health∼Holland, Topsector Life Sciences & Health
Spatium Medical B.V.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
12 children for whom informed consent will be obtained from their parents and from the child.
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of adverse device events as assessed by observations during the procedure (qualitative measurements) | During surgery | Observations of researcher and surgeon (number of adverse device events) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of intra-abdominal pressure stability, assessed by the median and interquartile range of the actual measured pressure | 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) | 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. | 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 calculating the abdominal compliance; quantitative measurements) | During surgery | Intra-abdominal pressure and intra-abdominal flow data recording during surgical procedure. |
Countries
Netherlands
Contacts
CONTACTA.I. Jong
CONTACTJ. Vlot
PRINCIPAL_INVESTIGATORJ. Vlot
Erasmus Medical Center
Outcome results
None listed