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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor (Excluding CNS)
• Intervention / Treatment: Procedure: High-Frequency Jet Ventilation (HFJV)

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.

• Study Type: Interventional
• Enrollment (Estimated): 560
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nathalie DESFRICHES-DORIA; Phone Number: 0244768434; Email: nathalie.desfrichesdoria@chu-nantes.fr

Study Locations

• France
  • Lyon, France, 69008
    • Not yet recruiting
    • Centre Leon Berard
    • Contact: Alexandre MEYER; Phone Number: 0478782828; Email: alexandre.meyer@lyon.unicancer.fr
    • Principal Investigator: Alexandre MEYER
    • Sub-Investigator: Gaëlle BOUROCHE
  • Lyon, France, 69002
    • Not yet recruiting
    • CHU de Lyon
    • Contact: Stéphanie CLERC; Phone Number: 0472118088; Email: stephanie.clerc@chu-lyon.fr
    • Principal Investigator: Stéphanie CLERC
    • Sub-Investigator: Emma AKA
  • Nantes, France, 44093
    • Recruiting
    • CHU de Nantes
    • Contact: Nathalie DESFRICHES-DORIA; Phone Number: 0244768434; Email: nathalie.desfrichesdoria@chu-nantes.fr
    • Principal Investigator: Nathalie DESFRICHES-DORIA
    • Sub-Investigator: Nicolas GRILLOT
  • Nîmes, France, 30900
    • Not yet recruiting
    • CHU de Nîmes
    • Contact: Natacha SIMON-MONNIER; Phone Number: 0466686868; Email: natacha.simon@chu-nimes.fr
    • Principal Investigator: Natacha SIMON-MONNIER
    • Sub-Investigator: Danielle GARNIER
  • Poitiers, France, 86000
    • Not yet recruiting
    • Chu de Poitiers
    • Contact: Anne MERCIER; Phone Number: 0615052500; Email: anne.mercier@chu-poitiers.fr
    • Principal Investigator: Anne MERCIER
    • Sub-Investigator: Denis FRASCA
  • Saint-Herblain, France, 44800
    • Not yet recruiting
    • ICO Unicancer
    • Contact: Roland MARTIN; Phone Number: 0240679900; Email: roland.martin@ico-unicancer.fr
    • Principal Investigator: Roland MARTIN
    • Sub-Investigator: Vincent LE NESTOUR
  • Villejuif, France, 94800
    • Recruiting
    • Institut Gustave Roussy
    • Contact: Sandrine GARDE; Phone Number: 0142116724; Email: sandrine.garde@gustaveroussy.fr
    • Principal Investigator: Sandrine GARDE
    • Sub-Investigator: Emma EVRARD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Driving pressure with a fixed setting of 1.4 bars; 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); 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.
Active Comparator: Driving pressure with a fixed setting of 1.9 bars; 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); 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.
Active Comparator: Driving pressure with a fixed setting of 2.4 bars; 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); 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.
Experimental: Driving pressure with a personalized setting; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%.	Immediately after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	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	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	Immediately after the procedure
Oxygen saturation	Variation in SpO2	Immediately after the procedure
Nu-Desc score	Change in the Nu-Desc score in the post-anesthesia care unit	At day 0
Patient's surgical pathway	Duration in post-intervention care unit	From time of randomization until the time of care unit discharge assessed up to one day
Patient journey during the stay	Duration of stay	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	At day 0
Sweating	Occurence of sweating in the post-anesthesia care unit	At day 0

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2026
• Primary Completion (Estimated): March 13, 2028
• Study Completion (Estimated): March 13, 2028

Study Registration Dates

• First Submitted: January 21, 2026
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Anesthesia; Interventional Radiology; Ventilation; High-Frequency Jet Ventilation; Tumor ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Pathological Conditions, Signs and Symptoms; Respiratory Aspiration; Therapeutics; Airway Management; Respiratory Therapy; Respiration, Artificial; High-Frequency Ventilation; High-Frequency Jet Ventilation
• Other Study ID Numbers: RC24_0606

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No