An interventional study of High-Frequency Jet Ventilation (HFJV) in Solid Tumor (Excluding CNS), sponsored by Nantes University Hospital. Recruiting at 7 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Nantes University Hospital · Not applicable, Interventional, and Treatment
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.
1,092 studies on the registry are indexed under Respiratory Aspiration; 216 are open to participants now.
This study's planned enrollment of 560 is above the median of 42 across 881 interventional studies indexed under Respiratory Aspiration.
Browse Respiratory Aspiration studies →Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.
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Exclusion Criteria:
On the day of the interventional radiology surgery (Day 0), the driving pressure setting will be of 1.4 bars.
Procedure: High-Frequency Jet Ventilation (HFJV)
On the day of the interventional radiology surgery (Day 0), the driving pressure setting will be of 1.9 bars.
Procedure: High-Frequency Jet Ventilation (HFJV)
On the day of the interventional radiology surgery (Day 0), the driving pressure setting will be of 2.4 bars.
Procedure: High-Frequency Jet Ventilation (HFJV)
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
Procedure: 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.
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 : * 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%.
Time frame: Immediately after the procedure
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
Time frame: Immediately after the procedure
Efficiency of the personalized setting compared to a fixed setting of 1.9 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 1.9 bars
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Immediately after the procedure
Oxygen saturation
Variation in SpO2
Time frame: Immediately after the procedure
Nu-Desc score
Change in the Nu-Desc score in the post-anesthesia care unit
Time frame: At day 0
Patient's surgical pathway
Duration in post-intervention care unit
Time frame: From time of randomization until the time of care unit discharge assessed up to one day
Patient journey during the stay
Duration of stay
Time frame: 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
Time frame: At day 0
Sweating
Occurence of sweating in the post-anesthesia care unit
Time frame: At day 0
Plan to share: Undecided
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