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Review Board stopped the study after interim analysis reaching stopping rule for efficacy.
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| Name | Class |
|---|---|
| Fundación Mutua Madrileña | OTHER |
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | 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. |
|
| 2 | No Intervention | Standard therapy for severe post-traumatic hypoxia: pain control with epidural anesthesia and oxygen. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-invasive ventilation | Device | Applied continuously for the first 24 hours, then every 24 hours, trial of discontinuation. Interface specific for the associated injuries. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intubation rate | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Pneumothorax rate | 1 month | |
| Pneumonia rate | 1 month | |
| Intensive Care Unit stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gonzalo Hernandez, Dr. | Hospital Virgen de la Salud | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital 12 de Octubre | Madrid | Madrid | 28045 | Spain | ||
| Hospital Virgen de la Salud |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11867822 | Result | British Thoracic Society Standards of Care Committee. Non-invasive ventilation in acute respiratory failure. Thorax. 2002 Mar;57(3):192-211. doi: 10.1136/thorax.57.3.192. No abstract available. | |
| 19749006 | Derived | Hernandez G, Fernandez R, Lopez-Reina P, Cuena R, Pedrosa A, Ortiz R, Hiradier P. Noninvasive ventilation reduces intubation in chest trauma-related hypoxemia: a randomized clinical trial. Chest. 2010 Jan;137(1):74-80. doi: 10.1378/chest.09-1114. Epub 2009 Sep 11. |
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| ID | Term |
|---|---|
| D063087 | Noninvasive Ventilation |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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| 2 months |
| Toledo |
| Toledo |
| 45004 |
| Spain |