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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNantes University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patient under guardianship or curatorship.

Patient who does not understand French.

Pregnant and breastfeeding woman

Patient who has had a pneumonectomy

Trial design

Design model

Parallel

Treatments tested in this trial

  • High-Frequency Jet Ventilation (HFJV)

    Procedure/Surgery

    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.

Treatment groups

560 Participants
are divided into 4 treatment groups
Group A: Driving pressure with a fixed setting of 1.4 barsActive comparator 1 intervention
Group B: Driving pressure with a fixed setting of 1.9 barsActive comparator 1 intervention
Group C: Driving pressure with a fixed setting of 2.4 barsActive comparator 1 intervention
Group D: Driving pressure with a personalized settingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

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