Effect of a Driving Pressure Adjustment Procedure for High-Frequency Jet Ventilation in Patients Undergoing Tumor Thermal Ablation in Interventional Radiology (Pulmojet 3)

Nantes University Hospital (NUH)

Status: Enrolling

Conditions: Solid Tumor (Excluding CNS)

Treatments: Procedure: High-Frequency Jet Ventilation (HFJV)

Study type: Interventional

Funder types: Other

Identifiers

NCT07408375

RC24_0606

Details and patient eligibility

About

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.

Full 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.

Enrollment: 560 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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560 participants in 4 patient groups

Driving pressure with a fixed setting of 1.4 bars

Active Comparator group

Description:

On the day of the interventional radiology surgery (Day 0), the driving pressure setting will be of 1.4 bars.

Treatment:

Procedure: High-Frequency Jet Ventilation (HFJV)

Driving pressure with a fixed setting of 1.9 bars

Active Comparator group

Description:

On the day of the interventional radiology surgery (Day 0), the driving pressure setting will be of 1.9 bars.

Treatment:

Procedure: High-Frequency Jet Ventilation (HFJV)

Driving pressure with a fixed setting of 2.4 bars

Active Comparator group

Description:

On the day of the interventional radiology surgery (Day 0), the driving pressure setting will be of 2.4 bars.

Treatment:

Procedure: High-Frequency Jet Ventilation (HFJV)

Driving pressure with a personalized setting

Experimental group

Description:

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

Treatment:

Procedure: High-Frequency Jet Ventilation (HFJV)