Observational Study on Respiratory Impact of High-frequency Jet Ventilation (JVHF) in Interventional Radiology (RI) (Pulmojet)

Jet ventilation is used in interventional radiology to reduce respiratory movement and facilitate tumor destruction. The purpose of this study is to describe the respiratory impact of this technique

Study Overview

• Status: Completed
• Conditions: Anesthesia Complication

Detailed Description

Use imaging and respiratory data to describe the impact of JVHF during tumor thermoablation procedures

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44093
    • Nantes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study will be offered to patients benefiting from thermoablation of abdominal tumors under JVHF. Recruitment will take place during the pre-anesthetic consultation.

Description

Inclusion Criteria:

• Major patient
• Patient benefiting from an abdominal tumor thermoablation procedures
• Patient who gave consent
• Patient with a social protection scheme

Exclusion Criteria:

• Pulmonary thermoablation procedures
• Thermoablation of abdominal tumors required a transpleural passage
• Patient under guardianship or curatorship
• Patient not understanding French

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluate the respiratory impact after the use of JVHF after thermoablation of a solid abdominal tumour.	Respiratory complication rate.	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Describe the number of ventilatory disorders	Score Radiological Atelectasis Score (RAS) of Richter Larsen - RAS: 0, clear lung field; 1, plate like atelectasis or slight infiltration; 2, partial atelectasis; 3, lobar atelectasis; 4, bilateral lobar atelectasis.	through study completion, an average of 1 year
Describe the incidence of hypoxemia during JVHF	Difference between oxygen saturation at the end of the procedure and at the beginning of the procedure	through study completion, an average of 1 year
Describe the incidence of hypercapnia at the time of a JVHF	Difference between end of procedure and beginning of procedure capnia	through study completion, an average of 1 year
Describe the incidence of barotraumatic pulmonary lesions at the time of a JVHF	Presence of barotraumatic pulmonary lesions on the imaging	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2020
• Primary Completion (Actual): November 23, 2020
• Study Completion (Actual): November 23, 2020

Study Registration Dates

• First Submitted: December 20, 2019
• First Submitted That Met QC Criteria: December 20, 2019
• First Posted (Actual): December 24, 2019

Study Record Updates

• Last Update Posted (Actual): September 13, 2021
• Last Update Submitted That Met QC Criteria: September 10, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: RC19_0416

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No