Evaluation of fixed versus variable dosing of 4-factor prothrombin complex concentrate for emergent warfarin reversal.

STUDY OBJECTIVE: This study compares the safety and efficacy of a fixed dose of 4-factor prothrombin complex concentrate (4FPCC) to the FDA-approved variable dosing for reversal of warfarin-induced anticoagulation. METHODS: This was a single-center, prospective, open-label, randomized controlled trial with subjects randomized to 4FPCC at a fixed dose of 1500 IU or the FDA-approved variable dosing regimen. The primary efficacy outcome (reversal success) was defined as a post-intervention international normalized ratio (INR) of less than or equal to 1.5. Given that 4FPCC is the standard of care for reversal of warfarin-induced anticoagulation an active-controlled approach was employed with the two dosing regimens compared based on efficacy, cost, and safety outcomes. RESULTS: 71 subjects (34 in the fixed dose group and 37 in the variable dose group) completed the study. There were no significant differences in age, gender, weight, initial INR, or indication for 4FPCC administration between the two treatment groups. Reversal success in the fixed-dose group was 61.8%, while in the variable dose group reversal success was 89.2%. Reversal success in the fixed-dose group was significantly lower than the rate of reversal success in the variable dose group (27.4% lower, p = 0.011). CONCLUSION: The results of this study provide evidence that fixed dosing results in lower reversal success rates as compared to variable dosing of 4FPCC for warfarin-induced anticoagulation.

The Minnesota mobile extracorporeal cardiopulmonary resuscitation consortium for treatment of out-of-hospital refractory ventricular fibrillation: Program description, performance, and outcomes.

BACKGROUND: We describe implementation, evaluate performance, and report outcomes from the first program serving an entire metropolitan area designed to rapidly deliver extracorporeal membrane oxygenation (ECMO)-facilitated resuscitation to patients with refractory ventricular fibrillation/ventricular tachycardia (VF/VT) out-of-hospital cardiac arrest (OHCA). METHODS: This observational cohort study analyzed consecutive patients prospectively enrolled in the Minnesota Mobile Resuscitation Consortium's ECMO-facilitated resuscitation program. Entry criteria included: 1) adults (aged 18-75), 2) VF/VT OHCA, 3) no return of spontaneous circulation following 3 shocks, 4) automated cardiopulmonary resuscitation with a Lund University Cardiac Arrest System (LUCAS™), and 5) estimated transfer time of < 30 min. The primary endpoint was functionally favorable survival to hospital discharge with Cerebral Performance Category (CPC) 1 or 2. Secondary endpoints included 3-month functionally favorable survival, program benchmarks, ECMO cannulation rate, and safety. Essential program components included emergency medical services, 3 community ECMO Initiation Hospitals with emergency department ECMO cannulation sites and 24/7 cardiac catheterization laboratories, a 24/7 mobile ECMO cannulation team, and a single, centralized ECMO intensive care unit. FINDINGS: From December 1, 2019 to April 1, 2020, 63 consecutive patients were transported and 58 (97%) met criteria and were treated by the mobile ECMO service. Mean age was 57 ± 1.8 years; 46/58 (79%) were male. Program benchmarks were variably met, 100% of patients were successfully cannulated, and no safety issues were identified. Of the 58 patients, 25/58 (43% [CI:31-56%]) were both discharged from the hospital and alive at 3 months with CPC 1 or 2. INTERPRETATION: This first, community-wide ECMO-facilitated resuscitation program in the US demonstrated 100% successful cannulation, 43% functionally favorable survival rates at hospital discharge and 3 months, as well as safety. The program provides a potential model of this approach for other communities. FUNDING: The Helmsley Charitable Trust.

Placement of a cervical collar increases the optic nerve sheath diameter in healthy adults.

INTRODUCTION: Blunt head trauma is a common cause of increased intracranial pressure (ICP). Ultrasound measurement of the optic nerve sheath diameter (OSND) is an accurate and non-invasive way to detect increased ICP. Blunt trauma patients are often immobilized in a rigid cervical spine collar. Our objective was to describe the changes in ONSD following the placement of a c-collar and determine if any changes were time-dependent. METHODS: We performed a prospective cohort study measuring the ONSD of healthy volunteers before and after placement of a c-collar. Two physicians obtained the measurements. Each eye was scanned twice using a standardized technique. This was done before c-collar placement, 5min after placement and 20min after placement. A mean of both eyes was calculated and analyzed using descriptive statistics. An intraclass correlation coefficient (ICC) was used to assess inter-rater reliability. RESULTS: Twenty study participants with a mean age of 37.1years old were enrolled. The mean baseline ONSD was 3.77mm (95% CI 3.48-4.07). The mean ONSD 5 min after the c-collar was placed was 4.47 (95% CI 4.17-4.78). The mean ONSD at 20min after c-collar placement was 4.53 (95% CI 4.13-4.92). These changes were statistically significant (p=0.003 and <0.001). Reliability was relatively strong overall (ICC=0.74; 95% CI: 0.65, 0.81). CONCLUSION: The placement of a cervical collar increased the ONSD at 5min and this change remained increased at 20min. Future study should assess whether similar results are found in patients with blunt head trauma.

Evaluation of the Storz CMAC®, Glidescope® GVL, AirTraq®, King LTS-D™, and direct laryngoscopy in a simulated difficult airway.

OBJECTIVE: The aim of this study was to compare first-attempt and overall success rates and success rates in relation to placement time among 5 different airway management devices: Storz CMAC, Glidescope GVL, AirTraq, King LTS-D, and direct laryngoscopy (DL). METHODS: Emergency medical technician basic (EMT-B), EMT-paramedics (EMT-P), and emergency medicine residents and staff physicians placed each of the 5 devices in a random order into an AirSim (TruCorp, Belfast, UK) part-task training manikin. The difficult airway scenario was created by fixing the manikin head to a stationary object and introducing simulated emesis into the hypopharynx. First-attempt and overall success and success in relation to placement time were compared. Provider feedback about device performance was also evaluated. RESULTS: Ninety-four providers (16 EMT-basics, 54 EMT-paramedics, and 24 emergency department doctors of medicine) consented to participation. First-attempt and overall success rates for DL, King LTS-D, GVL, and CMAC were not statistically different. Compared with DL, the AirTraq was 96% less likely to be placed successfully (odds ratio, 0.04; 95% confidence interval [CI], 0.01-0.14). When time was factored into the model, the odds of successful placement of the King LTS-D were higher compared with DL (hazard ratio [HR], 1.80; 95% CI, 1.34-2.42) and lower for GVL (HR, 0.59; 95% CI, 0.44-0.80) and AirTraq (HR, 0.228; 95% CI, 0.16-0.325). Providers ranked the CMAC first in terms of performance and preference for use in their practice setting. CONCLUSION: Overall success rates for DL, King-LTS-D, and both video laryngoscope systems were not different. When time was factored into the model, the King LTS-D was more likely to be placed successfully.