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

NCT07408375 | Recruiting

• 1 other identifier: RC24_0606
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 7

Brief 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. 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.

Conditions

Solid Tumor (Excluding CNS)

Keywords

Ventilation; High-Frequency Jet Ventilation; Anesthesia; Interventional Radiology; Tumor ablation

Outcome Measures

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%.

  Immediately after the procedure

Secondary Outcomes (14)

• Efficiency of the personalized setting compared to a fixed setting of 1.4 bars

  Immediately after the procedure

• Efficiency of the personalized setting compared to a fixed setting of 1.9 bars

  Immediately after the procedure

• Efficiency of the personalized setting compared to a fixed setting 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

  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

  Immediately after the procedure

Study Arms (4)

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.

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.

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.

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

Procedure: High-Frequency Jet Ventilation (HFJV)

Interventions

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (7)

CHU de Lyon

Lyon, 69002, France

NOT YET RECRUITING

Centre Léon Bérard

Lyon, 69008, France

NOT YET RECRUITING

CHU de Nantes

Nantes, 44093, France

RECRUITING

CHU de Nîmes

Nîmes, 30900, France

NOT YET RECRUITING

CHU de Poitiers

Poitiers, 86000, France

NOT YET RECRUITING

ICO Unicancer

Saint-Herblain, 44800, France

NOT YET RECRUITING

Institut Gustave Roussy

Villejuif, 94800, France

RECRUITING

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

High-Frequency Jet Ventilation

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

High-Frequency Ventilation; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Central Study Contacts

Nathalie DESFRICHES-DORIA

CONTACT

0244768434; nathalie.desfrichesdoria@chu-nantes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: February 13, 2026
• Study Start: March 13, 2026
• Primary Completion (Estimated): March 13, 2028
• Study Completion (Estimated): March 13, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

FR (7)