Efficacy of Non-Invasive Mechanical Ventilation in Early Hypoxia Secondary to Thoracic Trauma
Phase 4
Terminated
- Conditions
- Post-Traumatic Respiratory Failure
- Interventions
- Device: Non-invasive ventilation
- Registration Number
- NCT00557752
- Lead Sponsor
- Hospital Virgen de la Salud
- Brief Summary
* Severe post-traumatic hypoxia is mainly due to lung contusion. The intubation rate of these patients is near 20%.
* Treatment before intubation is needed, is based on pain control with epidural anesthesia and oxygen.
* The investigators' hypothesis is that adding non-invasive mechanical ventilation to the standard treatment can reduce the intubation rate if applied early in the course of the disease.
* As thoracic trauma is often associated with injuries in other body regions that may increase the complications of the technique, specific contraindications have been described.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- Age > 18 years.
- Informed consent obtained.
- pO2/FiO2 <200 for more than 8 consecutive hours in the first 48 hours after thoracic trauma.
Exclusion Criteria
- Orotracheal intubation indicated for any other reason.
- Standard contraindication for non-invasive ventilation (active gastro-intestinal haemorrhage, low level of consciousness, multiorgan failure, airway control problems, lack of cooperation, hemodynamic instability).
- Severe traumatic brain injury.
- Facial trauma with pneumocephalus, skull base fracture, orbit base fracture, any facial fracture involving a sinus.
- Cervical injury with specific treatment contraindicating a facial mask.
- Bronco-pleural fistula.
- Gastro-intestinal trauma.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Non-invasive ventilation Addition to the standard therapy of non-invasive mechanical ventilation. Continuously for the first 24 hours, then trials to discontinuation every 24 hours. Interface adjusted for the associated injuries.
- Primary Outcome Measures
Name Time Method Intubation rate 1 month
- Secondary Outcome Measures
Name Time Method Pneumothorax rate 1 month Pneumonia rate 1 month Intensive Care Unit stay 2 months
Trial Locations
- Locations (2)
Hospital 12 de Octubre
🇪🇸Madrid, Spain
Hospital Virgen de la Salud
🇪🇸Toledo, Spain