Actively Recruiting
Effects of Non-invasive Ventilation Therapies on the Lung in Hypoxemic Chest Trauma Patients
Led by Hospices Civils de Lyon · Updated on 2025-06-24
30
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Chest trauma is common in traumatology. Its management is based on ventilatory therapies, among which non-invasive ventilation (NIV) is commonly used. Some studies have shown the benefit of this therapy in hypoxemic patients, avoiding intubation, reducing length of stay and healthcare costs, and even reducing mortality. However, these studies are old and underpowered. High flow oxygen therapy (HFO), which is frequently used in everyday practice, has only one study in chest trauma. There is still a lack of data to really understand the effects of these techniques on the injured lung after trauma. Therefore, the investigators want to do a NIV or HFO session and directly assess the effects on participants' lungs by doing a CT at the end of the session. This is a procedure carried out within five days of the initial trauma and consists of either a 10-minute session of non-invasive ventilation or a 10-minute session of high-flow oxygen therapy, depending on which arm the participant is allocated to. Two chest CTs will be performed: the first as part of usual care before the non-invasive ventilation session or high flow oxygen therapy session, and the second immediately after the 10-minute session. The investigator's objective is to demonstrate an improvement in lung recruitment with NIV or HFO using CT imaging.
CONDITIONS
Official Title
Effects of Non-invasive Ventilation Therapies on the Lung in Hypoxemic Chest Trauma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years old
- Chest trauma occurred less than 5 days ago
- At least 3 rib fractures visible on initial CT scan
- Moderate oxygen need to maintain oxygen saturation (SpO2 > 92%) or PaO2/FiO2 ratio > 200
- Admitted to Intensive Care Unit
- Require a chest CT scan within five days after trauma
You will not qualify if you...
- Patient is intubated or has respiratory failure with PaO2/FiO2 < 200 or needs intubation (including respiratory rate > 35/min, heavy tracheal secretions, increased accessory muscle use, respiratory exhaustion, pH < 7.3, PaCO2 > 50 mmHg, severe hypoxemia with PaO2/FiO2 < 100, or oxygen desaturation < 88% for more than 5 minutes)
- Unable to hold breath for 10 seconds needed for scan
- Received NIV or HFO ventilatory support within 12 hours before the study
- Uncontrolled circulatory failure needing Noradrenaline > 0.15 ug/kg/min
- Uncontrolled neurological failure with Glasgow Coma Scale less than 15
- Unstable facial trauma, pneumocephalus, or basilar skull trauma
- Large undrained pneumothorax with more than 2 cm separation at hilum
- Identified cognitive impairment
- Persons deprived of liberty or under protective legal measures
- Not affiliated with social security insurance
- Currently pregnant or breastfeeding
- Refusal to participate in the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hopital Edouard Herriot
Lyon, Rhône, France, 69003
Actively Recruiting
Research Team
S
Stanislas ABRARD, MD
CONTACT
V
Valerie Cerro
CONTACT
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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