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

Hospital Virgen de la Salud

Status and phase: Terminated; Phase 4

Conditions: Post-Traumatic Respiratory Failure

Treatments: Device: Non-invasive ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT00557752

06001-00

Details and patient eligibility

About

• 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

1

Active Comparator group

Description:

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.

Treatment:

Device: Non-invasive ventilation

2

No Intervention group

Description:

Standard therapy for severe post-traumatic hypoxia: pain control with epidural anesthesia and oxygen.