Effect of a Driving Pressure Adjustment Procedure for High-Frequency Jet Ventilation in Patients Undergoing Tumor Thermal Ablation in Interventional Radiology
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High-Frequency Jet Ventilation (HFJV).
- Who it may be relevant to
- Registry conditions: Solid Tumor (Excluding CNS). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- 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.
Primary outcome measures
- Efficacy on respiratory function of a personalized strategy for adjusting the driving pressure of the HFJV [Time frame: Immediately after the procedure]
Secondary outcome measures (12)
- 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]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 7 centers
- CHU de Lyon — Lyon
- Centre Léon Bérard — Lyon
- CHU de Nantes — Nantes
- CHU de Nîmes — Nîmes
- CHU de Poitiers — Poitiers
- ICO Unicancer — Saint-Herblain
- Institut Gustave Roussy — Villejuif
Identifiers
NCT: NCT07408375 · RC24_0606