Driving pressure adjustment for high-frequency jet ventilation during tumor ablation
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
This study will test whether using a height-based driving pressure for high-frequency jet ventilation improves breathing stability during thermal ablation in adults with non-brain solid tumors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 560 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 7 sites (Lyon and 6 other locations) |
| Trial ID | NCT07408375 on ClinicalTrials.gov |
What this trial studies
Patients undergoing percutaneous thermal ablation of solid tumors under general anesthesia will receive high-frequency jet ventilation with the driving pressure randomly assigned on the day of procedure to 1.4, 1.9, 2.4 bars, or a height-based customized setting. The trial measures respiratory function and motion control during the ablation to see how driving pressure affects imaging localization and procedure precision. High-frequency jet ventilation delivers small tidal volumes at high frequency to minimize respiratory movement while maintaining oxygenation. The goal is to determine whether a height-adjusted pressure reduces motion and improves conditions for complete tumor destruction while protecting adjacent organs.
Who should consider this trial
Good fit: Adults (≥18 years) scheduled for thermal ablation of a non-central-nervous-system solid tumor under high-frequency jet ventilation who can give informed consent and meet airway and general eligibility criteria.
Not a fit: Patients who are pregnant or breastfeeding, have had a pneumonectomy, require an endotracheal tube smaller than 6.5 mm, are under guardianship, or cannot understand French are not likely to be eligible or to benefit from this protocol.
Why it matters
Potential benefit: If successful, height-based driving pressure settings could reduce respiratory motion during ablation, improving targeting accuracy and potentially lowering damage to nearby organs.
How similar studies have performed: High-frequency jet ventilation is an established technique to reduce respiratory motion during image-guided ablation, but using a height-based driving pressure is a relatively novel, less-tested approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Lyon and 6 other locations
- CHU de Lyon — Lyon, France (Not_yet_recruiting)
- Centre Léon Bérard — Lyon, France (Not_yet_recruiting)
- CHU de Nantes — Nantes, France (Recruiting)
- CHU de Nîmes — Nîmes, France (Not_yet_recruiting)
- CHU de Poitiers — Poitiers, France (Not_yet_recruiting)
- ICO Unicancer — Saint-Herblain, France (Not_yet_recruiting)
- Institut Gustave Roussy — Villejuif, France (Recruiting)
Study contacts
- Study coordinator: Nathalie DESFRICHES-DORIA
- Email: nathalie.desfrichesdoria@chu-nantes.fr
- Phone: 0244768434
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.