Muscle Oxygen Saturation Improves Diagnostic Association Between Initial Vital Signs and Major Hemorrhage: A Prospective Observational Study

OBJECTIVES: During initial assessment of trauma patients, vital signs do not identify all patients with life‐threatening hemorrhage. We hypothesized that a novel vital sign, muscle oxygen saturation (SmO(2)), could provide independent diagnostic information beyond routine vital signs for identification of hemorrhaging patients who require packed red blood cell (RBC) transfusion. METHODS: This was an observational study of adult trauma patients treated at a Level I trauma center. Study staff placed the CareGuide 1100 tissue oximeter (Reflectance Medical Inc., Westborough, MA), and we analyzed average values of SmO(2), systolic blood pressure (sBP), pulse pressure (PP), and heart rate (HR) during 10 minutes of early emergency department evaluation. We excluded subjects without a full set of vital signs during the observation interval. The study outcome was hemorrhagic injury and RBC transfusion ≥ 3 units in 24 hours (24‐hr RBC ≥ 3). To test the hypothesis that SmO(2) added independent information beyond routine vital signs, we developed one logistic regression model with HR, sBP, and PP and one with SmO(2) in addition to HR, sBP, and PP and compared their areas under receiver operating characteristic curves (ROC AUCs) using DeLong's test. RESULTS: We enrolled 487 subjects; 23 received 24‐hr RBC ≥ 3. Compared to the model without SmO(2), the regression model with SmO(2) had a significantly increased ROC AUC for the prediction of ≥ 3 units of 24‐hr RBC volume, 0.85 (95% confidence interval [CI], 0.75–0.91) versus 0.77 (95% CI, 0.66–0.86; p < 0.05 per DeLong's test). Results were similar for ROC AUCs predicting patients (n = 11) receiving 24‐hr RBC ≥ 9. CONCLUSIONS: SmO(2) significantly improved the diagnostic association between initial vital signs and hemorrhagic injury with blood transfusion. This parameter may enhance the early identification of patients who require blood products for life‐threatening hemorrhage.