Rationale: Less invasive, nonsurgical approaches are needed to treat severe emphysema.Objectives: To evaluate the effectiveness and safety of the Spiration Valve System (SVS) versus optimal medical management.Methods: In this multicenter, open-label, randomized, controlled trial, subjects aged 40 years or older with severe, heterogeneous emphysema were randomized 2:1 to SVS with medical management (treatment) or medical management alone (control).Measurements and Main Results: The primary efficacy outcome was the difference in mean FEV1 from baseline to 6 months. Secondary effectiveness outcomes included: difference in FEV1 responder rates, target lobe volume reduction, hyperinflation, health status, dyspnea, and exercise capacity. The primary safety outcome was the incidence of composite thoracic serious adverse events. All analyses were conducted by determining the 95% Bayesian credible intervals (BCIs) for the difference between treatment and control arms. Between October 2013 and May 2017, 172 participants (53.5% male; mean age, 67.4 yr) were randomized to treatment (n = 113) or control (n = 59). Mean FEV1 showed statistically significant improvements between the treatment and control groups—between-group difference at 6 and 12 months, respectively, of 0.101 L (95% BCI, 0.060–0.141) and 0.099 L (95% BCI, 0.048–0.151). At 6 months, the treatment group had statistically significant improvements in all secondary endpoints except 6-minute-walk distance. Composite thoracic serious adverse event incidence through 6 months was greater in the treatment group (31.0% vs. 11.9%), primarily due to a 12.4% incidence of serious pneumothorax.Conclusions: In patients with severe heterogeneous emphysema, the SVS shows significant improvement in multiple efficacy outcomes, with an acceptable safety profile.Clinical trial registered with www.clinicaltrials.gov (NCT01812447).

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ClinicalTrials.gov; No.: NCT01752114; URL: www.clinicaltrials.gov).

This approach yields good to excellent discriminatory performance among adult inpatients for predicting sepsis present on admission or developed within the hospital and may aid in the timely delivery of care.

The time for arterial PO2 to reach equilibrium after a 0.2 increase in the fraction of inspired oxygen (FIO2) was studied, using arterial blood gases measured at 1, 2, 3, 4, 5, 7, 9, and 11 min in 30 stable, mechanically ventilated medical intensive care unit (ICU) patients. Eight patients also underwent a 0.4 increase in FIO2. Each patient's rise in PO2 over time [PO2(t)] was fit to the following exponential equation: PO2(t) = PO2i + (PO2f-PO2i) (1-e-kt), where t refers to time, PO2i and PO2f refer to the initial and final equilibrated PO2. The time constant k and PO2f were determined by a nonlinear curve fitting technique. The 90% oxygenation times (t90%), defined as the time required to reach 90% of the final equilibrated PO2, were calculated. The mean t90% (+/- SD) was 6.0 (+/- 3.4) min for all patients (range 1.7 to 14.3 min); 7.1 +/- 2.1 min for 18 patients with chronic obstructive pulmonary disease (COPD) and 4.4 +/- 2.0 min for 12 patients without COPD (p < 0.05). In the subgroup of patients undergoing both an FIO2 increase of 0.2 and 0.4, there was no significant difference in the mean t90%'s for the two FIO2 changes (7.7 versus 7.7 min). We conclude that after a 0.2 or 0.4 increase of FIO3, a 15-min equilibration time period is adequate for 90% of the increase in PO2 to occur, in stable, mechanically ventilated medical ICU patients.