Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06735872

Effects of Non-invasive Ventilation and High-flow Oxygen Therapy on the Lung in Hypoxemic Chest Trauma Patients, a Descriptive Experimental CT Scan Study

Led by Hospices Civils de Lyon · Updated on 2025-06-24

30

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the effects of non-invasive ventilation (NIV) and high flow oxygen therapy (HFO) on the lungs of patients who have suffered chest trauma. The goal is to better understand how these breathing support methods impact lung function shortly after injury, as previous studies are limited and outdated. This study is sponsored by Hospices Civils de Lyon and focuses on patients with hypoxemic chest trauma, using CT scans to measure lung changes. Participants will be randomly assigned to receive either a single 10-minute session of non-invasive ventilation delivered through a naso-buccal mask or a 10-minute session of high flow oxygen therapy delivered via nasal cannula. Both sessions occur directly on the CT scan table. Two chest CT scans are performed: one before the breathing support session as part of usual care and another immediately after the session to assess changes in lung volume and recruitment. During the study, a senior intensivist will monitor participants for comfort and safety. Researchers will evaluate lung volume changes at day 0 using the CT images. The study involves patients admitted to intensive care within five days of chest trauma who require oxygen support and follow-up chest CTs. Participation includes the treatment session and two CT scans, with the primary outcome focused on lung volume improvement after intervention.

CONDITIONS

Brief Title

Effects of Non-invasive Ventilation Therapies on the Lung in Hypoxemic Chest Trauma Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years old
  • Chest trauma occurred within the last 5 days
  • At least 3 ribs fractured on the initial CT scan
  • Require moderate oxygen support to maintain oxygen saturation over 92% or PaO2/FiO2 ratio above 200
  • Admitted to Intensive Care Unit
  • Need a chest CT scan within the first five days after trauma
Not Eligible

You will not qualify if you...

  • Patient is intubated or has respiratory failure indicated by PaO2/FiO2 below 200 or need for intubation
  • Unable to hold breath for 10 seconds required for CT scan
  • Received non-invasive ventilation or high flow oxygen therapy in the 12 hours before the study
  • Uncontrolled circulatory failure requiring high-dose Noradrenaline
  • Uncontrolled neurological failure with Glasgow Coma Scale below 15
  • Unstable facial trauma, pneumocephalus, or basilar skull trauma
  • Large, untreated pneumothorax with significant lateral separation
  • Cognitive impairment
  • Persons deprived of liberty or under protective measures
  • Not affiliated with social security insurance
  • Current pregnancy or breastfeeding
  • Refusal to participate in the study

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single session on day 0

Participants receive a single 10-minute session of either non-invasive ventilation or high flow oxygen therapy directly on the CT table. A senior intensivist monitors participant comfort and safety during the session.

1 visit (in-person) including chest CT and treatment

Trial Site Locations

Total: 1 location

1

Hopital Edouard Herriot

Lyon, Rhône, France, 69003

Actively Recruiting

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Research Team

S

Stanislas ABRARD, MD

V

Valerie Cerro

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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