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Completed

NCT Number: NCT04209608

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

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

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Key information

Conditions

Anesthesia Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nantes University Hospital

Nantes, 44093, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. evaluate the respiratory impact after the use of JVHF after thermoablation of a solid abdominal tumour.

    Time frame: through study completion, an average of 1 year

    Respiratory complication rate.

Secondary outcomes

  1. Describe the number of ventilatory disorders

    Time frame: 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.

  2. Describe the incidence of hypoxemia during JVHF

    Time frame: 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

  3. Describe the incidence of hypercapnia at the time of a JVHF

    Time frame: through study completion, an average of 1 year

    Difference between end of procedure and beginning of procedure capnia

  4. Describe the incidence of barotraumatic pulmonary lesions at the time of a JVHF

    Time frame: through study completion, an average of 1 year

    Presence of barotraumatic pulmonary lesions on the imaging

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: Pulmojet

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 24, 2019
Registry last updated
Sep 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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