The Turbine-based CO2 Insufflator Pediatric Feasibility Study (TuBa)

The Use of the Turbine-based CO2 Insufflator in Pediatric Laparoscopic Surgery - a Feasibility Trial

A novel CO2 insufflator, the turbine-based insufflator, has been developed to improve minimal 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 turbine-based insufflator, and comparison of ventiliation pressures between these insufflators.

Study Overview

• Status: Recruiting
• Conditions: Pneumoperitoneum; Laparoscopy
• Intervention / Treatment: Device: Turbine-based insufflator

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.

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: A.I. Jong; Phone Number: +31107037641; Email: a.i.dejong@erasmusmc.nl
• Study Contact Backup: Name: J. Vlot; Phone Number: +31107039568

Study Locations

• Netherlands
  • South Holland
    • Rotterdam, South Holland, Netherlands, 3015 GD
      • Recruiting
      • Erasmus MC, University Medical Center Rotterdam
      • Contact: J. Vlot; Phone Number: +31107039568; Email: john.vlot@erasmusmc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Weight ≥ 10 kilograms (kg);
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pediatric laparoscopy; Pediatric population, planned for intraperitoneal laparoscopic surgery.	Device: Turbine-based insufflator; Use of the tubine-based insufflator during surgical procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	During surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During surgery
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.	Between turbine-based insufflation and conventional insufflation.	During surgery
Abdominal compliance by performing endoscopic oscillometry in a pediatric population (using insufflation pressure and flow for calculaing the abodminal compliance; quantitative measurements)	Intra-abdominal pressure and intra-abdominal flow data recording during surgical procedure.	During surgery

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Collaborators: Health∼Holland, Topsector Life Sciences & Health; Politecnico di Milano University; Spatium Medical B.V.
• Investigators: Principal Investigator: J. Vlot, Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 27, 2026
• First Submitted That Met QC Criteria: July 20, 2026
• First Posted (Actual): July 21, 2026

Study Record Updates

• Last Update Posted (Actual): July 21, 2026
• Last Update Submitted That Met QC Criteria: July 20, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Pneumoperitoneum; Laparoscopy; Device development; Insufflator
• Additional Relevant MeSH Terms: Digestive System Diseases; Peritoneal Diseases; Pneumoperitoneum
• Other Study ID Numbers: NL-010054

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No