High Frequency Jet Ventilation for Percutaneous Interventional Radiology
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|ClinicalTrials.gov Identifier: NCT02813005|
Recruitment Status : Unknown
Verified June 2016 by University Hospital, Strasbourg, France.
Recruitment status was: Recruiting
First Posted : June 24, 2016
Last Update Posted : February 20, 2017
Evaluate benefits of High Frequency Jet Ventilation compare to standard ventilation during general anesthesia in patient undergoing peri diaphragmatic percutaneous tumor ablation.
The investigators hypothesis that procedure is shorter and more accurate in High Frequency Jet Ventilation group reducing target movement induced by ventilation.
|Condition or disease||Intervention/treatment||Phase|
|Percutaneous Tumor Ablation||Procedure: Jet ventilation group Procedure: Standard ventilation group||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||108 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||High Frequency Jet Ventilation for Percutaneous Interventional Radiology|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||August 2018|
Experimental: Jet ventilation/ group A
Frequency : 120-200/min Pressure : 1-2 bars Inspiratory fraction of oxygen : 100% and 50% if Expiratory pressure : 5 -10 cmH2O
Procedure: Jet ventilation group
MONSOON III™ (Acutronic Medical System AG®, SEBAC) with Double lumen catheter 12CH (Acutronic Medical System AG®, SEBAC)
Other Name: Frequence: 120-200/min; Pressure: 1-2 bars; Inspiratory fraction of Oxgen: 50%; Expiratory pressure: 5-10 cmH2O
Sham Comparator: Standard ventilation/ group B
Apnea made by the anesthesiologist to the request of the radiologist.
Procedure: Standard ventilation group
apnea made by the anesthesiologist to the request of the radiologist
Other Name: apnea made by the anesthesiologist with Primus DRAGER Medical
- Time to hit the target [ Time Frame: during the procedure ]Estimated the time for a puncture needle under High Frequency Jet Ventilation compared to the conventional mode of mechanical ventilation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813005
|Contact: Sandra PETIOT, MD||+33 369550443||Sandra.Petiot@chru-strasbourg.fr|
|Hôpitaux Universitaires de Starsbourg||Recruiting|
|Strasbourg, France, 67091|
|Principal Investigator:||Sandra PETIOT, MD||Les Hôpitaux Universitaires de Strasbourg|