Effects of Non-invasive Ventilation Therapies on the Lung in Hypoxemic Chest Trauma Patients (NCT06735872) | Clinical Trial Compass
RecruitingNot Applicable
Effects of Non-invasive Ventilation Therapies on the Lung in Hypoxemic Chest Trauma Patients
France30 participantsStarted 2025-04-22
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age \> 18 years old
* Chest trauma \< 5 days
* At least 3 ribs fracture on initial CT-scan
* Need of oxygen moderated to maintain monitoring oxygen saturation Sp02 \> 92% or partial pressure of arterial oxygen Pa02/ Fraction of inspired oxygen FiO2 \> 200
* Intensive Care Unit admission
* Need a chest CT control during the five first days after the trauma
Exclusion Criteria:
* Patient intubated or with respiratory failure : measured or estimated Pa02/FiO2 \< 200 or indication for intubation (several with respiratory rate \> 35/min, abundant tracheal secretions, significant increase in work of accessory respiratory muscles on inspiration, signs of respiratory exhaustion on arterial blood gas with The potential of Hydrogen pH \< 7,3 or PaCO2 \> 50 mmHg, severe hypoxemia with PaO2/FiO2 ratio \< 100 or desaturation \< 88% for more than 5 minutes)
* Inability to maintain 10 seconds of apnoea required for scan acquisition
* Patient treated with ventilatory support by NIV or HFO in the 12 hours prior the investigation
* Uncontrolled circulatory failure with need for introduction of Noradrenaline \> 0,15 ug/kg/min
* Uncontrolled neurological failure with Glasgow Coma Scale (CGS \< 15
* Unstable facial trauma or with pneumocephalus or basilar skull trauma
* Large, undrained pneumothorax with lateral separation at the level of the hilum \> 2 cm and extensive throughout the axillary line
* Patients with identified cognitive impairment
* Persons …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.