Solid Tumor (Excluding CNS)Pulmojet 3NCT07408375
Effect of a Driving Pressure Adjustment Procedure for High-Frequency Jet Ventilation in Patients Undergoing Tumor Thermal Ablation in Interventional Radiology
A study testing High-Frequency Jet Ventilation (HFJV) in people with Solid Tumor (Excluding CNS), run by Nantes University Hospital at 7 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor (Excluding CNS)
- What is being tested?
- High-Frequency Jet Ventilation (HFJV)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 7 sitesFrance
- Study dates
- 13 Mar 2026to 13 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites, 7 recruiting
- Recruiting
CHU de Lyon
Lyon, 69002
Stéphanie CLERC, 0472118088, stephanie.clerc@chu-lyon.fr
Stéphanie CLERC
- Recruiting
CHU de Nantes
Nantes, 44093
Nathalie DESFRICHES-DORIA, 0244768434, nathalie.desfrichesdoria@chu-nantes.fr
Nathalie DESFRICHES-DORIA
- Not yet recruiting
CHU de Nîmes
Nîmes, 30900
Natacha SIMON-MONNIER, 0466686868, natacha.simon@chu-nimes.fr
Natacha SIMON-MONNIER
- Not yet recruiting
Hôpital Européen Georges Pompidou (HEGP)
Paris, 75015
Guillaume HERAUD, 0156093011, heraudg@hotmail.com
Guillaume HERAUD
- Recruiting
CHU de Poitiers
Poitiers, 86000
Anne MERCIER, 0615052500, anne.mercier@chu-poitiers.fr
Anne MERCIER
- Recruiting
ICO Unicancer
Saint-Herblain, 44800
Roland MARTIN, 0240679900, roland.martin@ico-unicancer.fr
Roland MARTIN
- Recruiting
Institut Gustave Roussy
Villejuif, 94800
Sandrine GARDE, 0142116724, sandrine.garde@gustaveroussy.fr
Sandrine GARDE
About this study
Official 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
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.
Read more
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.
Read the 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)
- Being tested
- High-Frequency Jet Ventilation (HFJV)
- Keywords
- Ventilation, High-Frequency Jet Ventilation, Anesthesia, Interventional Radiology, Tumor ablation
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Frequency Jet Ventilation (HFJV)Procedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Driving pressure with a fixed setting of 1.4 bars | Active comparator | On the day of the interventional radiology surgery (Day 0), the driving pressure setting will be of 1.4 bars. Receives: Procedure: High-Frequency Jet Ventilation (HFJV) |
| Driving pressure with a fixed setting of 1.9 bars | Active comparator | On the day of the interventional radiology surgery (Day 0), the driving pressure setting will be of 1.9 bars. Receives: Procedure: High-Frequency Jet Ventilation (HFJV) |
| Driving pressure with a fixed setting of 2.4 bars | Active comparator | On the day of the interventional radiology surgery (Day 0), the driving pressure setting will be of 2.4 bars. Receives: Procedure: High-Frequency Jet Ventilation (HFJV) |
| Driving pressure with a personalized setting | Experimental | 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 Receives: Procedure: High-Frequency Jet Ventilation (HFJV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: Immediately after the procedure
Secondary outcomes (14)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Immediately after the procedure
Oxygen saturation
Variation in SpO2
Measured: Immediately after the procedure
Nu-Desc score
Change in the Nu-Desc score in the post-anesthesia care unit
Measured: At day 0
Patient's surgical pathway
Duration in post-intervention care unit
Measured: From time of randomization until the time of care unit discharge assessed up to one day
Patient journey during the stay
Duration of stay
Measured: 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
Measured: At day 0
Sweating
Occurence of sweating in the post-anesthesia care unit
Measured: At day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start13 Mar 2026
- Primary completion13 Mar 2028 (estimated)
- Study completion13 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor (Excluding CNS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07408375
- Sponsor's protocol ID
- RC24_0606
- Acronym
- Pulmojet 3
- Status last verified
- Oct 2026
- First submitted
- 21 Jan 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07408375
- Acronym / sponsor ID
- Pulmojet 3 / RC24_0606
- Conditions
- Solid Tumor (Excluding CNS)
- Keywords
- Ventilation, High-Frequency Jet Ventilation, Anesthesia, Interventional Radiology, Tumor ablation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 13 Mar 2026 (actual)
- Primary completion
- 13 Mar 2028 (estimated)
- Study completion
- 13 Mar 2028 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Driving pressure with a fixed setting of 1.4 bars | Active comparator | Procedure: High-Frequency Jet Ventilation (HFJV)On the day of the interventional radiology surgery (Day 0), the driving pressure setting will be of 1.4 bars. |
| Driving pressure with a fixed setting of 1.9 bars | Active comparator | Procedure: High-Frequency Jet Ventilation (HFJV)On the day of the interventional radiology surgery (Day 0), the driving pressure setting will be of 1.9 bars. |
| Driving pressure with a fixed setting of 2.4 bars | Active comparator | Procedure: High-Frequency Jet Ventilation (HFJV)On the day of the interventional radiology surgery (Day 0), the driving pressure setting will be of 2.4 bars. |
| Driving pressure with a personalized setting | Experimental | Procedure: High-Frequency Jet Ventilation (HFJV)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Driving pressure with a fixed setting of 1.4 bars, Driving pressure with a fixed setting of 1.9 bars, Driving pressure with a fixed setting of 2.4 bars, Driving pressure with a personalized setting |
Primary outcome
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%.
14 secondary outcomes
Efficiency of the personalized setting compared to a fixed setting of 1.4 bars
Time frame: Immediately after the procedure
Efficiency of the personalized setting compared to a fixed setting of 1.9 bars
Time frame: Immediately after the procedure
Efficiency of the personalized setting compared to a fixed setting of 2.4 bars
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Immediately after the procedure
Risk factors for respiratory complications
Time frame: Immediately after the procedure
Oxygen saturation
Time frame: Immediately after the procedure
Nu-Desc score
Time frame: At day 0
Patient's surgical pathway
Time frame: From time of randomization until the time of care unit discharge assessed up to one day
Patient journey during the stay
Time frame: From time of randomization until the time of hospital discharge assessed up to one day
Headache
Time frame: At day 0
Sweating
Time frame: At day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Frequency Jet Ventilation (HFJV) in people with Solid Tumor (Excluding CNS), run by Nantes University Hospital at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nathalie DESFRICHES-DORIA (0244768434, nathalie.desfrichesdoria@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy on respiratory function of a personalized strategy for adjusting the driving pressure of the HFJV (time frame: Immediately after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.