An interventional study of Turbine-based insufflator in Laparoscopy and Pneumoperitoneum, sponsored by Erasmus Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-05.
Sponsored by Erasmus Medical Center · Not applicable, Interventional, and Device feasibility
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.
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.
149 studies on the registry are indexed under Pneumoperitoneum; 29 are open to participants now.
This study's enrollment of 12 is below the median of 79 across 96 interventional studies indexed under Pneumoperitoneum.
Browse Pneumoperitoneum studies →Erasmus Medical Center is the lead sponsor of 466 studies on the registry; 179 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Adult study participants who are planned to undergo intraperitoneal laparoscopic surgery
Device: Turbine-based insufflator
The use of a turbine-based insufflator instead of a conventional insufflator
Occurrence of (serious) adverse device effects [Safety and feasibility of the device]
Recording all adverse device effects as defined in the study protocol
Time frame: During the surgical procedure
Observation of insufflation pressure stability by continuously monitoring and recording.
Assessment of stability of the intra-abdominal pressure generated by the device during the surgical procedure using descriptive statistics of deviation from set-pressure.
Time frame: During the surgical procedure
Gas volume exchange
Determination of the gas volume exchange required to keep insufflation pressures stable.
Time frame: During the surgical procedure
Estimation of the abdominal compliance
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.
Time frame: <6 months after the surgical procedure
Intra-abdominal target pressure in relation to the abdominal compliance
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.
Time frame: <6 months after the surgical procedure
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Erasmus Medical Center