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

Completed

• Conditions: Anesthesia Complication

• Registration Number: NCT04209608
• Lead Sponsor: Nantes University Hospital

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2019-12-20
• Study First Submitted QC: 2019-12-20
• Study First Posted: 2019-12-24
• Study Start: 2020-03-12
• Primary Completion: 2020-11-23
• Study Completion: 2020-11-23
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-10
• Last Update Posted: 2021-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Describe the incidence of hypercapnia at the time of a JVHF	through study completion, an average of 1 year	Difference between end of procedure and beginning of procedure capnia
Describe the number of ventilatory disorders	through study completion, an average of 1 year	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.
Describe the incidence of hypoxemia during JVHF	through study completion, an average of 1 year	Difference between oxygen saturation at the end of the procedure and at the beginning of the procedure
Describe the incidence of barotraumatic pulmonary lesions at the time of a JVHF	through study completion, an average of 1 year	Presence of barotraumatic pulmonary lesions on the imaging

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, France