Efficacy of Non-Invasive Mechanical Ventilation in Early Hypoxia Secondary to Thoracic Trauma

Study Overview
=================
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.

Official Title
-----------------
Non-Invasive Ventilation in Early Severe Posttraumatic Hypoxia: a Randomized Controlled Trial

Conditions
-----------------
Post-Traumatic Respiratory Failure

Intervention / Treatment
-----------------
* Device: Non-invasive ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>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. | Device: Non-invasive ventilation<br>* Applied continuously for the first 24 hours, then every 24 hours, trial of discontinuation. Interface specific for the associated injuries.<br>|
| No Intervention: 2<br>Standard therapy for severe post-traumatic hypoxia: pain control with epidural anesthesia and oxygen. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation rate |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pneumothorax rate |  | 1 month | 
| Pneumonia rate |  | 1 month | 
| Intensive Care Unit stay |  | 2 months |