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NCT Number: NCT07408375

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

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.

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Key information

Conditions

Solid Tumor (Excluding CNS) Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Lyon, Lyon, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Efficacy on respiratory function of a personalized strategy for adjusting the driving pressure of the HFJV

    Time frame: Immediately after the procedure

    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%.

Secondary outcomes

  1. Efficiency of the personalized setting compared to a fixed setting of 1.4 bars

    Time frame: Immediately after the procedure

    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

  2. Efficiency of the personalized setting compared to a fixed setting of 1.9 bars

    Time frame: Immediately after the procedure

    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

  3. Efficiency of the personalized setting compared to a fixed setting of 2.4 bars

    Time frame: Immediately after the procedure

    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

  4. Efficiency for each of the four events comprising the composite criterion of the customized setting compared to all three other groups

    Time frame: Immediately after the procedure

    Occurrence of each of the four events of the composite criterion in the personalized setting group and in all three other groups

  5. Efficiency for each of the four events comprising the composite criterion, of the customized setting compared to a fixed setting of 1.4 bars

    Time frame: Immediately after the procedure

    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

  6. Efficiency for each of the four events comprising the composite criterion, of the customized setting compared to a fixed setting of 1.9 bars

    Time frame: Immediately after the procedure

    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

  7. Efficiency for each of the four events comprising the composite criterion, of the customized setting compared to a fixed setting of 2.4 bars

    Time frame: Immediately after the procedure

    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

  8. Risk factors for respiratory complications

    Time frame: Immediately after the procedure

    Patient and HFJV intervention characteristics associated with the occurrence of respiratory complications during JVHF at T1

  9. Oxygen saturation

    Time frame: Immediately after the procedure

    Variation in SpO2

  10. Nu-Desc score

    Time frame: At day 0

    Change in the Nu-Desc score in the post-anesthesia care unit

  11. Patient's surgical pathway

    Time frame: From time of randomization until the time of care unit discharge assessed up to one day

    Duration in post-intervention care unit

  12. Patient journey during the stay

    Time frame: From time of randomization until the time of hospital discharge assessed up to one day

    Duration of stay

  13. Headache

    Time frame: At day 0

    Occurence of headache in the post-anesthesia care unit

  14. Sweating

    Time frame: At day 0

    Occurence of sweating in the post-anesthesia care unit

Study contacts

Contact information is provided by the study sponsor or research team.

Nathalie DESFRICHES-DORIA

CONTACT

[email protected]

0244768434

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: Pulmojet 3

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 13, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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