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

Anesthesia Complication Clinical Trial

— Pulmojet  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04209608
• Other study ID #: RC19_0416
• Status: Completed
• Start date: March 12, 2020
• Est. completion date: November 23, 2020

Study information

• Verified date: September 2021
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 23, 2020
• Est. primary completion date: November 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia Complication

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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