Non-invasive ventilation versus high-flow oxygen for recent chest trauma
Effects of Non-invasive Ventilation and High-flow Oxygen Therapy on the Lung in Hypoxemic Chest Trauma Patients, a Descriptive Experimental CT Scan Study
We will try a 10-minute session of non-invasive ventilation or high-flow oxygen and then do a CT scan to see how each affects the lungs of adults hospitalized with hypoxemic chest trauma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Lyon, Rhône) |
| Trial ID | NCT06735872 on ClinicalTrials.gov |
What this trial studies
Adults admitted to ICU within five days of blunt chest trauma who have at least three rib fractures and moderate oxygen needs are randomly assigned to a 10-minute session of non-invasive ventilation (NIV) or high-flow oxygen (HFO). A chest CT is performed immediately after the session to directly image short-term changes in lung aeration and contusion. The protocol focuses on physiologic imaging endpoints rather than longer-term clinical outcomes such as intubation or length of stay. Investigators designed the approach because prior NIV studies are older and underpowered and HFO has very limited data in chest trauma.
Who should consider this trial
Good fit: Adult ICU patients within five days of chest trauma who have at least three rib fractures on initial CT and require moderate supplemental oxygen (SpO2 ≥ 92% or PaO2/FiO2 > 200) and who are scheduled for a chest CT are ideal candidates.
Not a fit: Patients who are intubated or in respiratory failure (PaO2/FiO2 ≤ 200 or clear indications for intubation), those with severe hypoxemia or inability to tolerate the breath-hold required for CT, or those outside the early post-trauma window are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could clarify which short-term respiratory support better improves lung aeration after chest trauma and help guide early therapy choices.
How similar studies have performed: Some older, small trials suggested NIV can avoid intubation and shorten stays in hypoxemic chest trauma, but the evidence is underpowered and HFO has only minimal study in this setting.
Eligibility criteria
Show full inclusion / exclusion criteria
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 deprived of liberty, persons under protective measures * Persons not affiliated to a social security insurance * Current pregnancy or breastfeeding * Refusal to participate in the study
Where this trial is running
Lyon, Rhône
- Hopital Edouard Herriot — Lyon, Rhône, France (Recruiting)
Study contacts
- Study coordinator: Stanislas ABRARD, MD
- Email: stanislas.abrard@chu-lyon.fr
- Phone: 04 72 11 69 44
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.