NCT06735872 Effects of Non-invasive Ventilation Therapies on the Lung in Hypoxemic Chest Trauma Patients
| NCT ID | NCT06735872 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospices Civils de Lyon |
| Condition | Lung Trauma |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-04-22 |
| Primary Completion | 2027-04-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-04-22 with a primary completion date of 2027-04-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06735872 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lung Trauma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06735872 currently recruiting?
Yes, NCT06735872 is actively recruiting participants. Contact the research team at stanislas.abrard@chu-lyon.fr for enrollment information.
Where is the NCT06735872 trial being conducted?
This trial is being conducted at Lyon, France.
Who is sponsoring the NCT06735872 clinical trial?
NCT06735872 is sponsored by Hospices Civils de Lyon. The trial plans to enroll 30 participants.