The Turbine-based Insufflator Safety and Feasibility Study : The Turbine-based Insufflator: a Safety and Feasibility Study During Laparoscopy.
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..
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Klinische Studie| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
ClinicalTrials.gov - (2024) vom: 19. März Zur Gesamtaufnahme - year:2024 |
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| Sprache: |
Englisch |
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| Links: |
Volltext [kostenfrei] |
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| Themen: |
610 |
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| Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: March 19, 2024, Last downloaded: ClinicalTrials.gov processed this data on March 27, 2024, Last updated: March 27, 2024 |
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| Study ID: |
NCT06319053 |
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| Veröffentlichungen zur Studie: |
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| PPN (Katalog-ID): |
CTG000110027 |
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| 520 | |a 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. | ||
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