High Frequency Jet Ventilation for Percutaneous Interventional Radiology

NCT ID: NCT02813005

Last Updated: 2017-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2018-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Percutaneous Tumor Ablation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Jet ventilation group

Intervention Type PROCEDURE

MONSOON III™ (Acutronic Medical System AG®, SEBAC) with Double lumen catheter 12CH (Acutronic Medical System AG®, SEBAC)

Standard ventilation/ group B

Apnea made by the anesthesiologist to the request of the radiologist.

Group Type SHAM_COMPARATOR

Standard ventilation group

Intervention Type PROCEDURE

apnea made by the anesthesiologist to the request of the radiologist

Interventions

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Jet ventilation group

MONSOON III™ (Acutronic Medical System AG®, SEBAC) with Double lumen catheter 12CH (Acutronic Medical System AG®, SEBAC)

Intervention Type PROCEDURE

Standard ventilation group

apnea made by the anesthesiologist to the request of the radiologist

Intervention Type PROCEDURE

Other Intervention Names

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Frequence: 120-200/min; Pressure: 1-2 bars; Inspiratory fraction of Oxgen: 50%; Expiratory pressure: 5-10 cmH2O apnea made by the anesthesiologist with Primus DRAGER Medical

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sandra PETIOT, MD

Role: PRINCIPAL_INVESTIGATOR

Les Hôpitaux Universitaires de Strasbourg

Locations

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Hôpitaux Universitaires de Starsbourg

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Sandra PETIOT, MD

Role: CONTACT

+33 369550443

Other Identifiers

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6370

Identifier Type: -

Identifier Source: org_study_id

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