NCT04209608

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 24, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

March 12, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2020

Completed
Last Updated

September 13, 2021

Status Verified

September 1, 2021

Enrollment Period

9 months

First QC Date

December 20, 2019

Last Update Submit

September 10, 2021

Conditions

Anesthesia Complication

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Describe the number of ventilatory disorders

    through study completion, an average of 1 year

  • Describe the incidence of hypoxemia during JVHF

    through study completion, an average of 1 year

  • Describe the incidence of hypercapnia at the time of a JVHF

    through study completion, an average of 1 year

  • Describe the incidence of barotraumatic pulmonary lesions at the time of a JVHF

    through study completion, an average of 1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

Location

Related Publications (1)

  • Trochu T, Desfriches-Doria N, Grillot N, Feuillet F, Lair D, Liberge R, Douane F, Dumont R, David A. Safety of High-Frequency Jet Ventilation During Image-Guided Thermal Ablation Procedures. Cardiovasc Intervent Radiol. 2023 Mar;46(3):360-368. doi: 10.1007/s00270-023-03358-5. Epub 2023 Jan 19.

    PMID: 36658374DERIVED

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2019

First Posted

December 24, 2019

Study Start

March 12, 2020

Primary Completion

November 23, 2020

Study Completion

November 23, 2020

Last Updated

September 13, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)