Post-Traumatic Respiratory Failure Clinical Trial
Official title:
Non-Invasive Ventilation in Early Severe Posttraumatic Hypoxia: a Randomized Controlled Trial
| Verified date | February 2009 |
| Source | Hospital Virgen de la Salud |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Spain: Ethics Committee |
| Study type | Interventional |
- 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.
| Status | Terminated |
| Enrollment | 50 |
| Est. completion date | June 2008 |
| Est. primary completion date | June 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital 12 de Octubre | Madrid | |
| Spain | Hospital Virgen de la Salud | Toledo |
| Lead Sponsor | Collaborator |
|---|---|
| Hospital Virgen de la Salud | Fundación Mutua Madrileña |
Spain,
British Thoracic Society Standards of Care Committee. Non-invasive ventilation in acute respiratory failure. Thorax. 2002 Mar;57(3):192-211. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Intubation rate | 1 month | No | |
| Secondary | Pneumothorax rate | 1 month | Yes | |
| Secondary | Pneumonia rate | 1 month | No | |
| Secondary | Intensive Care Unit stay | 2 months | No |