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Noninvasive ventilation reduces intubation in chest trauma-related hypoxemia: a randomized clinical trial
Hernandez G, Fernandez R, Lopez-Reina P, Cuena R, Pedrosa A, Ortiz R, Hiradier P
Chest 2010 Jan;137(1):74-80
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: Guidelines for noninvasive mechanical ventilation (NIMV) recommend continuous positive airway pressure in patients with thoracic trauma who remain hypoxic despite regional anesthesia. This recommendation is rated only by level C evidence because randomized controlled trials in this specific population are lacking. Our aim was to determine whether NIMV reduces intubation in severe trauma-related hypoxemia. METHODS: This was a single-center randomized clinical trial in a nine-bed ICU of a level I trauma hospital. Inclusion criteria were patients with PaO2/FiO2 < 200 for > 8 h while receiving oxygen by high-flow mask within the first 48 h after thoracic trauma. Patients were randomized to remain on high-flow oxygen mask or to receive NIMV. The interface was selected based on the associated injuries. Thoracic anesthesia was universally supplied unless contraindicated. The primary end point was intubation; secondary end points included length of hospital stay and survival. Statistical analysis was based on multivariate analysis. RESULTS: After 25 patients were enrolled in each group, the trial was prematurely stopped for efficacy because the intubation rate was much higher in controls than in NIMV patients (10 (40%) versus 3 (12%), p = 0.02). Multivariate analysis adjusted for age, gender, chronic heart failure, and Acute Physiology and Chronic Health Evaluation II at admission revealed NIMV as the only variable independently related to intubation (odds ratio 0.12; 95% CI 0.02 to 0.61; p = 0.01). Length of hospital stay was shorter in NIMV patients (14 versus 21 days, p = 0.001), but no differences were observed in survival or other secondary end points. CONCLUSION: NIMV reduced intubation compared with oxygen therapy in severe thoracic trauma-related hypoxemia. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT00557752.

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