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Идёт набор NCT07408375

Effect of a Driving Pressure Adjustment Procedure for High-Frequency Jet Ventilation in Patients Undergoing Tumor Thermal Ablation in Interventional Radiology

Без фазы С лечением Solid Tumor (Excluding CNS)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: High-Frequency Jet Ventilation (HFJV).
Кому может быть актуально
Состояния в реестре: Solid Tumor (Excluding CNS). Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Effect of a Driving Pressure Adjustment Procedure for High-Frequency Jet Ventilation in Patients Undergoing Tumor Thermal Ablation in Interventional Radiology - A Randomized, Controlled, Multicenter Study

Обзор

Tumor thermal ablation under Jet Ventilation is a procedure performed under general anesthesia that enables tumor ablation under radiological imaging guidance. This procedure, being less invasive than conventional surgery, allows for a faster recovery and hospital discharge. This procedure requires significant precision to ensure the most complete destruction of the tumor, while also preserving adjacent organs. During general anesthesia, respiratory movements complicate radiological localization and tumor destruction. The principle of High-Frequency Jet Ventilation (HFJV) involves using a device that ventilates a small volume of air and oxygen at a specific pressure, called driving pressure, at a high frequency. This ventilation mode reduces respiratory movements while ensuring continuous ventilation and oxygenation. This respiratory stability allows for the precision necessary to superimpose images for tumor localization and destruction. There are no guidelines regarding the driving pressure setting for HFJV for tumor thermal ablation. The method tested in this research is based on patient's height to optimize the driving pressure when using HFV. The main objective of this research is to evaluate the impact of driving pressure settings, on respiratory function, taking into account patient's height. On the day of the procedure, the driving pressure setting for the HFJV will be randomly assigned (1.4 bars, 1.9 bars, 2.4 bars, or customized according to the patient's height) (1 bar = 14 psi). The research will be conducted using medical data collected during routine patient care. Patient participation will last for the duration of their hospital stay, approximately two days.

Подробное описание

Tumor thermal ablation under Jet Ventilation is a procedure performed under general anesthesia that allows for the destruction of a tumor under radiological imaging guidance.

This procedure, less invasive than conventional surgery, allows for a faster recovery and return home. This procedure requires significant precision to ensure the most complete destruction of the tumor, while also preserving organs near the lesion. During general anesthesia, respiratory movements complicate radiological localization and tumor destruction.

The principle of High-Frequency Jet Ventilation (HFJV) involves using a device that ventilates a small volume of air and oxygen at a specific pressure, called driving pressure, at a high frequency.

This ventilation mode reduces respiratory movements while ensuring continuous ventilation and oxygenation. This respiratory stability allows for the precision necessary to superimpose images for tumor localization and destruction.

There are no recommendations regarding the driving pressure setting for HFJV for tumor thermal ablation. The method tested in this research is based on patient's height to optimize the driving pressure when using HFV.

The main objective of this research is to evaluate the impact of driving pressure settings, on respiratory function, taking into account patient's height.

On the day of the procedure, the driving pressure setting for the HFJV will be randomly assigned (1.4 bars, 1.9 bars, 2.4 bars, or customized according to the patient's height).

The research will be conducted using medical data collected during patient care. Patient participation will last for the duration of their hospital stay, approximately two days.

Вмешательства

  • Процедура High-Frequency Jet Ventilation (HFJV)
    High-Frequency Jet Ventilation (HFJV) involves ventilating with a small tidal volume of gas at a high frequency, ensuring diaphragmatic stability. This stability allows for the precise superimposition of localization and puncture images. HFJV is defined as a ventilation mode with very high insufflation rates (120 to 200 cycles per minute) delivering a low tidal volume through a catheter with a gauge of 13G to 16G.

Первичные конечные точки

  • Efficacy on respiratory function of a personalized strategy for adjusting the driving pressure of the HFJV [Срок оценки: Immediately after the procedure]
Вторичные конечные точки (12)
  • Efficiency of the personalized setting compared to a fixed setting of 1.4 bars [Срок оценки: Immediately after the procedure]
  • Efficiency of the personalized setting compared to a fixed setting of 1.9 bars [Срок оценки: Immediately after the procedure]
  • Efficiency of the personalized setting compared to a fixed setting of 2.4 bars [Срок оценки: Immediately after the procedure]
  • Efficiency for each of the four events comprising the composite criterion of the customized setting compared to all three other groups [Срок оценки: Immediately after the procedure]
  • Efficiency for each of the four events comprising the composite criterion, of the customized setting compared to a fixed setting of 1.4 bars [Срок оценки: Immediately after the procedure]
  • Efficiency for each of the four events comprising the composite criterion, of the customized setting compared to a fixed setting of 1.9 bars [Срок оценки: Immediately after the procedure]
  • Efficiency for each of the four events comprising the composite criterion, of the customized setting compared to a fixed setting of 2.4 bars [Срок оценки: Immediately after the procedure]
  • Risk factors for respiratory complications [Срок оценки: Immediately after the procedure]
  • Oxygen saturation [Срок оценки: Immediately after the procedure]
  • Nu-Desc score [Срок оценки: At day 0]
  • Patient's surgical pathway [Срок оценки: From time of randomization until the time of care unit discharge assessed up to one day]
  • Patient journey during the stay [Срок оценки: From time of randomization until the time of hospital discharge assessed up to one day]

Критерии участия

Критерии включения

  • Age ≥ 18 years.
  • Patient undergoing thermal ablation of a solid tumor under HFJV.
  • Patient who has given their consent.
  • Patient covered by a social security scheme.

Критерии исключения

  • Patient under guardianship or curatorship.
  • Patient who does not understand French.
  • Pregnant and breastfeeding woman
  • Patient who has had a pneumonectomy
  • Patient requiring an endotracheal tube smaller than 6.5

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Франция · 7 центров
  • CHU de Lyon — Lyon
  • Centre Léon Bérard — Lyon
  • CHU de Nantes — Nantes
  • CHU de Nîmes — Nîmes
  • CHU de Poitiers — Poitiers
  • ICO Unicancer — Saint-Herblain
  • Institut Gustave Roussy — Villejuif

Идентификаторы

NCT: NCT07408375 · RC24_0606

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗