The turbine-based insufflator: a clinical safety and feasibility study during laparoscopy

The turbine-based insufflator: a clinical safety and feasibility study during laparoscopy - Turbine-based insufflator

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON56486

Enrollment

Registered

2024-02-13

Start date

2024-04-03

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

geen specifieke aandoening, heeft betrekking op abdominale laparoscopische procedures Minimal access surgery for intra-abdominal pathology

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Adults (>=18 years old) - Elective surgery - Intraperitoneal laparoscopy - Planned use of a main 12 mm trocar

Exclusion criteria

Exclusion criteria: - Inability to contain the insufflation gas to the intraperitoneal space - Pregnancy

Design outcomes

Primary

Measure	Time frame
The number and nature of (serious) adverse device effects related to the turbine-based insufflator that occur during use.	—

Secondary

Measure	Time frame
- Determination of pressure stability throughout all procedures. - Identification of events that impair insufflation pressure stability. - Determination of the gas volume exchange required to keep insufflation pressures stable, absolute and in relation to ventilation tidal volumes. - Investigation of ventilator action and insufflator response in terms of amplitude and temporal offset. - Comparison between the insufflation pressure chosen by the surgeon and the optimal pressure derived from endoscopic oscillometry. - Evaluation of the applied pressure amplitudes and frequencies needed basing on patients weight and size, in order to get reference values of the abdominal cavitys compliance [L/hPa] in humans. - Evaluation of flows generated by the oscillation pressures applied for the purpose of sizing measuring instruments (flowmeters). - Evaluation of the range of frequencies used in oscillometry on patients* size and weight for estimating the compliance. - Comparison of pressure and flow time tracing both in ventilation and insufflation to derive the static compliance of the respiratory system. - Compensation of ventilation effects on pressure and flow signals. A post-processing analysis of the acquired signals will be done in order to filter out these effects and retain the information on the applied forced oscillations. - Optimization of endoscopic oscillometry in patients with different breathing rates.	—

Measure

Time frame

- Determination of pressure stability throughout all procedures. - Identification of events that impair insufflation pressure stability. - Determination of the gas volume exchange required to keep insufflation pressures stable, absolute and in relation to ventilation tidal volumes. - Investigation of ventilator action and insufflator response in terms of amplitude and temporal offset. - Comparison between the insufflation pressure chosen by the surgeon and the optimal pressure derived from endoscopic oscillometry. - Evaluation of the applied pressure amplitudes and frequencies needed basing on patient*s weight and size, in order to get reference values of the abdominal cavity*s compliance [L/hPa] in humans. - Evaluation of flows generated by the oscillation pressures applied for the purpose of sizing measuring instruments (flowmeters). - Evaluation of the range of frequencies used in oscillometry on patients* size and weight for estimating the compliance. - Comparison of pressure and flow time tracing both in ventilation and insufflation to derive the static compliance of the respiratory system. - Compensation of ventilation effects on pressure and flow signals. A post-processing analysis of the acquired signals will be done in order to filter out these effects and retain the information on the applied forced oscillations. - Optimization of endoscopic oscillometry in patients with different breathing rates.

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Countries

Netherlands

Outcome results