NCT07408375

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 560 (estimated)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumor (Excluding CNS)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-03-13
• Primary completion: 2028-03-13
• Completion: 2028-03-13
• First posted: 2026-02-13
• Last updated: 2026-03-27

Locations

7 sites across 1 country: France