Status:
RECRUITING
Optimization of Positive End Expiratory Pressure by Use of Pulmonary Ultrasound for Patients With Blunt Chest Trauma Treated by Non-Invasive Ventilation (Opti-PEP).
Lead Sponsor:
University Hospital, Montpellier
Conditions:
Thoracic Injuries
Non-invasive Ventilation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is an open-label, randomized controlled study comparing two non-invasive ventilation initiation strategies.Patients may be included if they present with acute respiratory failure related to blunt...
Detailed Description
This is an open-label, randomized controlled study comparing two non-invasive ventilation initiation strategies. Patients may be included if they are admitted to intensive care unit or continuing care...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 26 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06072339
Start Date
December 19 2023
End Date
December 26 2025
Last Update
October 4 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UH of Montpellier
Montpellier, France, 34295