Optimizing breathing support for patients with chest injuries using ultrasound
Optimization of Positive End Expiratory Pressure by Use of Pulmonary Ultrasound for Patients With Blunt Chest Trauma Treated by Non-Invasive Ventilation : Randomized Controlled Study (Opti-PEP).
This study is testing if using ultrasound to guide breathing support can help patients with chest injuries breathe better compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT06072339 on ClinicalTrials.gov |
What this trial studies
This open-label, randomized controlled study compares two strategies for initiating non-invasive ventilation in patients with acute respiratory failure due to blunt chest trauma. One group will receive standard care, while the intervention group will utilize pulmonary ultrasound to optimize Positive End Expiratory Pressure (PEEP) during their first session. The study aims to assess the effectiveness of this ultrasound-guided approach by measuring the PaO2/FiO2 ratio after 30 minutes of treatment. Eligible patients must be admitted to intensive or continuing care units and meet specific criteria related to their chest injuries.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with acute respiratory failure related to blunt chest trauma requiring non-invasive ventilation.
Not a fit: Patients who are in imminent need of invasive mechanical ventilation or have contraindications to non-invasive ventilation will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance oxygenation and improve respiratory outcomes for patients with blunt chest trauma.
How similar studies have performed: Other studies have shown promise in using ultrasound for respiratory management, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 18 or more * Admitted to intensive care or continuing care for 72 hours or less for blunt chest trauma, defined by the presence of at least one of the following elements on the initial CT scan: fracture(s) of rib(s) / fracture(s) of the sternum / pulmonary contusion / hemothorax * Acute hypoxemic respiratory failure defined by the administration of oxygen at least 3 L/min with nasal cannula or FiO2≥30% if high flow oxygen therapy. * Patient with a functional arterial catheter for blood tests Exclusion Criteria: * Acute respiratory distress, defined by the presence of at least one of the following clinical signs: respiratory rate ˃ 35 / use of accessory inspirators / paradoxal abdominal or thoracic motion * Imminent need for invasive mechanical ventilation * Usual contraindication to non-invasive ventilation (undrained pneumothorax, trauma to the face, vigilance disorders, digestive bleeding, hemodynamic instability, intolerance) * Hypercapnia (PaCO2˃45mmHg) * Patient unable to cooperate, communicate * Therapeutic limitation * Expected length of stay ≤ 48h * Severe head trauma * Pregnant or breastfeeding women * Participation in other clinical research related to respiratory failure/respiratory therapy * Vulnerable people * Protected adults, under guardianship or curatorship, or unable to give consent * Non-affiliated person or beneficiary of a social security scheme * Absence of free, informed and written consent, signed by the participant and the investigator
Where this trial is running
Montpellier
- UH of Montpellier — Montpellier, France (Recruiting)
Study contacts
- Study coordinator: David CHAPEAU, Physiotherapist
- Email: d-chapeau@chu-montpellier.fr
- Phone: 0467332688
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.