The Turbine-based Insufflator Safety and Feasibility Study (TBI)

Erasmus University

Status: Completed

Conditions: Laparoscopy; Pneumoperitoneum

Treatments: Device: Turbine-based insufflator

Study type: Interventional

Funder types: Other

Identifiers

NCT06319053

NL85402.078.23

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Laparoscopy

Experimental group

Description:

Adult study participants who are planned to undergo intraperitoneal laparoscopic surgery

Treatment:

Device: Turbine-based insufflator