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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 560
- 试验地点
- 7
- 主要终点
- Efficacy on respiratory function of a personalized strategy for adjusting the driving pressure of the HFJV
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Driving pressure with a fixed setting of 1.4 bars
On the day of the interventional radiology surgery (Day 0), the driving pressure setting will be of 1.4 bars.
干预措施: High-Frequency Jet Ventilation (HFJV) (Procedure)
Driving pressure with a fixed setting of 1.9 bars
On the day of the interventional radiology surgery (Day 0), the driving pressure setting will be of 1.9 bars.
干预措施: High-Frequency Jet Ventilation (HFJV) (Procedure)
Driving pressure with a fixed setting of 2.4 bars
On the day of the interventional radiology surgery (Day 0), the driving pressure setting will be of 2.4 bars.
干预措施: High-Frequency Jet Ventilation (HFJV) (Procedure)
Driving pressure with a personalized setting
On the day of the interventional radiology surgery (Day 0), the driving pressure setting will be personalized according to the patient's height : 1.4 bars if patient's height < 150 cm, 1.6 bars if patient's height is between 150 cm and 160 cm, 1.8 bars if patient's height is between 161 cm and 170 cm, 2.0 bars if patient's height is between 171 cm and 180 cm, 2.2 bars if patient's height is between 181 cm and 190 cm and 2.4 bars if patient's height > 190 cm
干预措施: High-Frequency Jet Ventilation (HFJV) (Procedure)
结局指标
主要结局
Efficacy on respiratory function of a personalized strategy for adjusting the driving pressure of the HFJV
时间窗: Immediately after the procedure
Occurrence of at least one of the following events : * Absolute change in FetCO2 of 8 mmHg between the baseline (T0) and the end of HFJV (T1), And/or * FetCO2 ≥ 45 mmHg at the end of the procedure, And/or * SpO2 \< 94% at the end of the procedure, And/or * Interruption of HFJV before the end of the procedure due to SpO2 ≤ 90%.
次要结局
- Efficiency of the personalized setting compared to a fixed setting of 1.4 bars(Immediately after the procedure)
- Efficiency of the personalized setting compared to a fixed setting of 1.9 bars(Immediately after the procedure)
- Efficiency of the personalized setting compared to a fixed setting of 2.4 bars(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(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(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(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(Immediately after the procedure)
- Risk factors for respiratory complications(Immediately after the procedure)
- Oxygen saturation(Immediately after the procedure)
- Nu-Desc score(At day 0)
- Patient's surgical pathway(From time of randomization until the time of care unit discharge assessed up to one day)
- Patient journey during the stay(From time of randomization until the time of hospital discharge assessed up to one day)
- Headache(At day 0)
- Sweating(At day 0)