Solid Tumor (Excluding CNS)
Conditions
Keywords
Ventilation, High-Frequency Jet Ventilation, Anesthesia, Interventional Radiology, Tumor ablation
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREHigh-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.
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy on respiratory function of a personalized strategy for adjusting the driving pressure of the HFJV | 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%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficiency of the personalized setting compared to a fixed setting of 1.4 bars | Immediately after the procedure | Occurrence of at least one of the four events comprising the main criterion, in the personalized setting group and in the fixed setting group of 1.4 bars |
| Efficiency of the personalized setting compared to a fixed setting of 1.9 bars | Immediately after the procedure | Occurrence of at least one of the four events comprising the main criterion, in the personalized setting group and in the fixed setting group of 1.9 bars |
| Efficiency of the personalized setting compared to a fixed setting of 2.4 bars | Immediately after the procedure | Occurrence of at least one of the four events comprising the main criterion in the personalized setting group and in the fixed setting group of 2.4 bars |
| 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 | Occurrence of each of the four events of the composite criterion in the personalized setting group and in all three other groups |
| 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 | Occurrence of each of the four events of the composite criterion in the personalized setting group and in the fixed setting group of 1.4 bars |
| 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 | Occurrence of each of the four events of the composite criterion in the personalized setting group and in the fixed setting group of 1.9 bars |
| 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 | Occurrence of each of the four events of the composite criterion in the personalized setting group and in the fixed setting group of 2.4 bars |
| Risk factors for respiratory complications | Immediately after the procedure | Patient and HFJV intervention characteristics associated with the occurrence of respiratory complications during JVHF at T1 |
| Oxygen saturation | Immediately after the procedure | Variation in SpO2 |
| Nu-Desc score | At day 0 | Change in the Nu-Desc score in the post-anesthesia care unit |
| Patient's surgical pathway | From time of randomization until the time of care unit discharge assessed up to one day | Duration in post-intervention care unit |
| Patient journey during the stay | From time of randomization until the time of hospital discharge assessed up to one day | Duration of stay |
| Headache | At day 0 | Occurence of headache in the post-anesthesia care unit |
| Sweating | At day 0 | Occurence of sweating in the post-anesthesia care unit |
Countries
France
Contacts
CONTACTNathalie DESFRICHES-DORIA
Outcome results
None listed