High Frequency Jet Ventilation for Percutaneous Interventional Radiology

University Hospital, Strasbourg, France

Status and phase: Unknown; Phase 3

Conditions: Percutaneous Tumor Ablation

Treatments: Procedure: Jet ventilation group; Procedure: Standard ventilation group

Study type: Interventional

Funder types: Other

Identifiers

NCT02813005

6370

Details and patient eligibility

About

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.

Enrollment: 108 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

Jet ventilation/ group A

Experimental group

Description:

Frequency : 120-200/min Pressure : 1-2 bars Inspiratory fraction of oxygen : 100% and 50% if Expiratory pressure : 5 -10 cmH2O

Treatment:

Procedure: Jet ventilation group

Standard ventilation/ group B

Sham Comparator group

Description:

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

Treatment:

Procedure: Standard ventilation group