CompletedInterventionalNot ApplicableUpdated Oct 2, 2025
Efficacy of Non-Invasive Mechanical Ventilation in Early Hypoxia Secondary to Thoracic Trauma | NCT00557752 | Trialant
TerminatedInterventionalPhase 4Updated Feb 9, 2009
Efficacy of Non-Invasive Mechanical Ventilation in Early Hypoxia Secondary to Thoracic Trauma
Non-Invasive Ventilation in Early Severe Posttraumatic Hypoxia: a Randomized Controlled Trial
ClinicalTrials.gov ID
NCT00557752
Lead Sponsor
Hospital Virgen de la SaludOTHER
Overall Status
Terminated
Study Type
Interventional
Phase
Phase 4
Enrollment
50Actual
Last Update Posted
Feb 9, 2009Estimated
Start Date
Sep 2005
Primary Completion Date
Jun 2008Actual
Completion Date
Jun 2008Actual
Official Title
Non-Invasive Ventilation in Early Severe Posttraumatic Hypoxia: a Randomized Controlled Trial
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.
Post-Traumatic Respiratory Failure
Non-invasive ventilation
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
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.