The Turbine-based CO2 Insufflator Pediatric Feasibility Study

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Turbine-based insufflator
  Use of the tubine-based insufflator during surgical procedure.

Первичные конечные точки

• The number of adverse device events as assessed by observations during the procedure (qualitative measurements) [Срок оценки: During surgery]

Вторичные конечные точки (4)

• Assessment of intra-abdominal pressure stability, assessed by the median and interquartile range of the actual measured pressure [Срок оценки: During surgery]
• Registration of events that impair intra-abdominal pressure stability (observationa, qualitative) [Срок оценки: 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. [Срок оценки: During surgery]
• Abdominal compliance by performing endoscopic oscillometry in a pediatric population (using insufflation pressure and flow for calculaing the abodminal compliance; quantitative measurements) [Срок оценки: During surgery]

Критерии участия

Критерии включения

• Weight ≥ 10 kilograms (kg);
• Laparoscopic procedure;
• Intraperitoneal procedure;
• Written informed consent.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Нидерланды · 1 центр

• Erasmus MC, University Medical Center Rotterdam — Rotterdam

Идентификаторы

NCT: NCT07715968 · NL-010054

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗