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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Driving pressure with a fixed setting of 1.4 bars | Active Comparator | On the day of the interventional radiology surgery (Day 0), the driving pressure setting will be of 1.4 bars. |
|
| Driving pressure with a fixed setting of 1.9 bars | Active Comparator | On the day of the interventional radiology surgery (Day 0), the driving pressure setting will be of 1.9 bars. |
|
| Driving pressure with a fixed setting of 2.4 bars | Active Comparator | On the day of the interventional radiology surgery (Day 0), the driving pressure setting will be of 2.4 bars. |
|
| Driving pressure with a personalized setting | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-Frequency Jet Ventilation (HFJV) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy on respiratory function of a personalized strategy for adjusting the driving pressure of the HFJV | Occurrence of at least one of the following events :
| Immediately after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Efficiency of the personalized setting compared to a fixed setting of 1.4 bars | 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 | Immediately after the procedure |
| Efficiency of the personalized setting compared to a fixed setting of 1.9 bars |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nathalie DESFRICHES-DORIA | Contact | 0244768434 | nathalie.desfrichesdoria@chu-nantes.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Lyon | Not yet recruiting | Lyon | 69002 | France |
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|
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 |
| Immediately after the procedure |
| Efficiency of the personalized setting compared to a fixed setting of 2.4 bars | 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 | 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 | Occurrence of each of the four events of the composite criterion in the personalized setting group and in 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 | 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 | 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 | 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 | 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 | 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 | Immediately after the procedure |
| Risk factors for respiratory complications | Patient and HFJV intervention characteristics associated with the occurrence of respiratory complications during JVHF at T1 | Immediately after the procedure |
| Oxygen saturation | Variation in SpO2 | Immediately after the procedure |
| Nu-Desc score | Change in the Nu-Desc score in the post-anesthesia care unit | At day 0 |
| Patient's surgical pathway | Duration in post-intervention care unit | From time of randomization until the time of care unit discharge assessed up to one day |
| Patient journey during the stay | Duration of stay | From time of randomization until the time of hospital discharge assessed up to one day |
| Headache | Occurence of headache in the post-anesthesia care unit | At day 0 |
| Sweating | Occurence of sweating in the post-anesthesia care unit | At day 0 |
| Centre Léon Bérard | Not yet recruiting | Lyon | 69008 | France |
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| CHU de Nantes | Recruiting | Nantes | 44093 | France |
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| CHU de Nîmes | Not yet recruiting | Nîmes | 30900 | France |
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| CHU de Poitiers | Not yet recruiting | Poitiers | 86000 | France |
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| ICO Unicancer | Not yet recruiting | Saint-Herblain | 44800 | France |
|
| Institut Gustave Roussy | Recruiting | Villejuif | 94800 | France |
|
| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D006611 | High-Frequency Jet Ventilation |
| ID | Term |
|---|---|
| D006612 | High-Frequency Ventilation |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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