High Frequency Jet Ventilation for Percutaneous Interventional Radiology

February 17, 2017 updated by: University Hospital, Strasbourg, France

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

108

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Hôpitaux Universitaires de Starsbourg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • apnea made by the anesthesiologist with Primus DRAGER Medical

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
during the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Sandra PETIOT, MD, Les Hôpitaux Universitaires de Strasbourg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

June 14, 2016

First Submitted That Met QC Criteria

June 23, 2016

First Posted (Estimate)

June 24, 2016

Study Record Updates

Last Update Posted (Actual)

February 20, 2017

Last Update Submitted That Met QC Criteria

February 17, 2017

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 6370

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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