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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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • use of percutaneous ablation tumor techniques (<3cm) for inferior lung, superior kidney, superior liver or adrenal gland lesion

Exclusion Criteria:

  • Severe chronic obstructive pulmonary disease
  • Recent pneumothorax (one month)
  • Recent thoracic surgery (one month)
  • Body Mass Index > 40

Information from the National Library of Medicine

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


Contacts
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Contact: Sandra PETIOT, MD +33 369550443 Sandra.Petiot@chru-strasbourg.fr

Locations
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France
Hôpitaux Universitaires de Starsbourg Recruiting
Strasbourg, France, 67091
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
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Principal Investigator: Sandra PETIOT, MD Les Hôpitaux Universitaires de Strasbourg
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02813005    
Other Study ID Numbers: 6370
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: February 20, 2017
Last Verified: June 2016
Keywords provided by University Hospital, Strasbourg, France:
High frequency jet ventilation