Efficacy of Non-Invasive Mechanical Ventilation in Early Hypoxia Secondary to Thoracic Trauma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|Primary Completion Date :||June 2008|
|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|