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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04209608

Acronym

Pulmojet

Enrollment

Registered

2019-12-24

Start date

2020-03-12

Completion date

2020-11-23

Last updated

2021-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia Complication

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 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 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

Countries

France

Outcome results