Laparoscopy, Pneumoperitoneum
Conditions
Keywords
Pneumoperitoneum, Device development, Insufflator, Laparoscopy
Brief summary
The turbine-based insufflator for minimal access surgery provides a new technological basis for minimal invasive surgery insufflation. Turbine technology permits highly accurate pressure control, an intra-abdominal volume that is dynamically adapted to ventilation, and oscillometric measurements of abdominal compliance. This first-in-human study aims to evaluate technologic feasibility in terms of pressure stability performance and the safety of the device.
Detailed description
The turbine-based insufflator for minimal access surgery provides a new technological basis for insufflation. Until now, insufflation uses a static pressurized gas volume that is strongly affected by external pressure and vice versa pressures onto the surrounding structures. Turbine technology permits highly accurate pressure control, and an intra-abdominal volume that is dynamically adapted to ventilation. In this safety and feasibility trial, the pressure stability of a turbine-based insufflator is investigated in patients undergoing laparoscopic surgery. In addition, small amplitude oscillation are superimposed to the intra-abdominal pressure at the start of insufflation. Those oscillometric measurements will be used to estimate the abdominal compliance through the forced oscillation technique. Study population: Adults who are scheduled for an elective intraperitoneal laparoscopic surgical procedure at Erasmus MC. Main study parameters: safety and feasibility of turbine-based insufflation in terms of (Serious) Adverse Device Effects.
Interventions
The use of a turbine-based insufflator instead of a conventional insufflator
Sponsors
Politecnico di Milano University
Health∼Holland, Topsector Life Sciences & Health
Spatium Medical B.V.
IDE Group B.V.
Erasmus Medical Center
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Consecutive patients from who informed consent can be acquired. The number of twelve participants was determined in conjunction with the Ethical Board of Erasmus MC
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult * Elective laparoscopic surgery * Intraperitoneal procedure * Planned use of a main 11 mm trocar * Informed consent
Exclusion criteria
* Pregnancy * Inability to contain the insufflation gas to the intraperitoneal cavity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of (serious) adverse device effects [Safety and feasibility of the device] | During the surgical procedure | Recording all adverse device effects as defined in the study protocol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimation of the abdominal compliance | <6 months after the surgical procedure | During the surgical procedure, oscillometry is performed with different frequencies and different pressures. Based on the acquired data the abdominal cavity's compliance will be determined by calculating the Impedance. |
| Intra-abdominal target pressure in relation to the abdominal compliance | <6 months after the surgical procedure | The target intra-abdominal pressure for the procedure as determined by the surgeon will be plotted on the compliance curve that is measured with oscillometry. Ultimately we aim to determine biomechanical optimum pressure based on oscillometry data. |
| Observation of insufflation pressure stability by continuously monitoring and recording. | During the surgical procedure | Assessment of stability of the intra-abdominal pressure generated by the device during the surgical procedure using descriptive statistics of deviation from set-pressure. |
| Gas volume exchange | During the surgical procedure | Determination of the gas volume exchange required to keep insufflation pressures stable. |
Countries
Netherlands
Outcome results
None listed