High Frequency Jet Ventilation for Percutaneous Interventional Radiology

Percutaneous Tumor Ablation Clinical Trial

Official title:

High Frequency Jet Ventilation for Percutaneous Interventional Radiology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02813005
• Other study ID #: 6370
• Status: Recruiting
• Phase: Phase 3
• First received: June 14, 2016
• Last updated: February 17, 2017
• Start date: July 2016
• Est. completion date: August 2018

Study information

• Verified date: June 2016
• Source: University Hospital, Strasbourg, France
• Contact: Sandra PETIOT, MD
• Phone: +33 369550443
• Email: Sandra.Petiot[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: August 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Percutaneous Tumor Ablation

Intervention

Procedure:
• Jet ventilation group
MONSOON III™ (Acutronic Medical System AG®, SEBAC) with Double lumen catheter 12CH (Acutronic Medical System AG®, SEBAC)
• Standard ventilation group
apnea made by the anesthesiologist to the request of the radiologist

Locations

Country	Name	City	State
France	Hôpitaux Universitaires de Starsbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to hit the target	Estimated the time for a puncture needle under High Frequency Jet Ventilation compared to the conventional mode of mechanical ventilation	during the procedure