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

Phase 4

Terminated

• Conditions: Post-Traumatic Respiratory Failure

• 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

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2007-11-13
• Study First Submitted QC: 2007-11-13
• Study First Posted: 2007-11-14
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-06
• Last Update Posted: 2009-02-09

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

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