Randomized controlled trial comparing pit crew resuscitation model against standard advanced life support training.

Objectives: Pit crew models are designed to improve teamwork in critical medical situations, like advanced life support (ALS). We investigated if a pit crew model training improves performance assessment and ALS skills retention when compared to standard ALS education. Methods: This was a prospective, blinded, randomized, and controlled, parallel-group trial. We recruited students to 4-person resuscitation teams. We video recorded simulated ALS-situations after the ALS education and after 6-month follow-up. We analyzed technical skills (TS) and non-technical skills (NTS) demonstrated in them with an instrument measuring TS and NTS, and used a linear mixed model to model the difference between the groups in the TS and NTS. Another linear model was used to explore the difference between the groups in hands-on ratio and hands-free time. The difference in the total assessment score was analyzed with the Mann-Whitney U-test. The primary outcome was the difference in the total assessment score between the groups at follow-up. ALS skills were considered to be a secondary outcome. Results: Twenty-six teams underwent randomization. Twenty-two teams received the allocated education. Fifteen teams were evaluated at 6-month follow-up: 7 in the intervention group and 8 in the control group. At 6-month follow-up, the median (Q1-Q3) total assessment score for the control group was 6.5 (6-8) and 7 (6.25-8) for the intervention group but the difference was not significant (U = 133, P = 0.373). The intervention group performed better in terms of chest compression quality (interaction term, ß3 = 0.23; 95% confidence interval, 0.01-0.50; P = 0.043) at follow-up. Conclusion: We found no difference in overall performance between the study arms. However, trends indicate that the pit crew model may help to retain ALS skills in different areas like chest compression quality.

Low- versus Mid-frequency Raman Spectroscopy for in Situ Analysis of Crystallization in Slurries.

Slurry studies are useful for exhaustive polymorph and solid-state stability screening of drug compounds. Raman spectroscopy is convenient for monitoring crystallization in such slurries, as the measurements can be performed in situ even in aqueous environments. While the mid-frequency region (400-4000 cm-1) is dominated by intramolecular vibrations and has traditionally been used for such studies, the low-frequency spectral region (<200 cm-1) probes solid-state related lattice vibrations and is potentially more valuable for understanding subtle and/or complex crystallization behavior. The aim of the study was to investigate low-frequency Raman spectroscopy for in situ monitoring of crystallization of an amorphous pharmaceutical in slurries for the first time and directly compare the results with those simultaneously obtained with mid-frequency Raman spectroscopy. Amorphous indomethacin (IND) slurries were prepared at pH 1.2 and continuously monitored in situ at 5 and 25 °C with both low- and mid-frequency Raman spectroscopy. At 25 °C, both spectral regions profiled amorphous IND in slurries as converting directly from the amorphous form toward the α crystalline form. In contrast, at 5 °C, principal component analysis revealed a divergence in the detected conversion profiles: the mid-frequency Raman suggested a direct conversion to the α crystalline form, but the low-frequency region showed additional transition points. These were attributed to the appearance of minor amounts of the ε-form. The additional solid-state sensitivity of the low-frequency region was attributed to the better signal-to-noise ratio and more consistent spectra in this region. Finally, the low-frequency Raman spectrum of the ε-form of IND is reported for the first time.

The effect of mechanical dry coating with magnesium stearate on flowability and compactibility of plastically deforming microcrystalline cellulose powders.

Mechanofusion is a dry coating method that can be used to improve the flowability of cohesive powder by coating host particles with a lubricant, for example magnesium stearate (MgSt). It has been shown previously that fragmenting material can under some circumstances be mechanofused with MgSt without impairing compactibility of the powder and without reducing the dissolution rate of the resulting tablets. However, the effects on material with viscoelastic behaviour, known to be sensitive for the negative effects of MgSt, is not known. Therefore, mechanofusion of microcrystalline cellulose (MCC) with MgSt was investigated in this study. Four MCC grades were mechanofused with different MgSt concentrations and process parameters, and the resulting flowability and compactibility were studied. Starting materials and low-shear blended binary mixtures were studied as a reference. Mechanofusion improved the flow properties of small particle size MCC powders (d50 < 78 µm) substantially, but increasing the MgSt content consequently resulted in weaker tablets. Larger particle size MCC grades, however, fractured under the shear forces during the mechanofusion process and hence their flow properties were decreased. Improvement of the flow properties but also the negative effects on compactibility of small particle size grades were observed even at relatively mild mechanofusion parameters and low lubricant concentrations.