Efficacy of Non-Invasive Mechanical Ventilation in Early Hypoxia Secondary to Thoracic Trauma
|ClinicalTrials.gov Identifier: NCT00557752|
Recruitment Status : Terminated (Review Board stopped the study after interim analysis reaching stopping rule for efficacy.)
First Posted : November 14, 2007
Last Update Posted : February 9, 2009
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Post-Traumatic Respiratory Failure||Device: Non-invasive ventilation||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Non-Invasive Ventilation in Early Severe Posttraumatic Hypoxia: a Randomized Controlled Trial|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||June 2008|
Active Comparator: 1
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
Applied continuously for the first 24 hours, then every 24 hours, trial of discontinuation. Interface specific for the associated injuries.
No Intervention: 2
Standard therapy for severe post-traumatic hypoxia: pain control with epidural anesthesia and oxygen.
- Intubation rate [ Time Frame: 1 month ]
- Pneumothorax rate [ Time Frame: 1 month ]
- Pneumonia rate [ Time Frame: 1 month ]
- Intensive Care Unit stay [ Time Frame: 2 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00557752
|Hospital 12 de Octubre|
|Madrid, Spain, 28045|
|Hospital Virgen de la Salud|
|Toledo, Spain, 45004|
|Principal Investigator:||Gonzalo Hernandez, Dr.||Hospital Virgen de la Salud|