Protocol for the "Michigan Awareness Control Study": A prospective, randomized, controlled trial comparing electronic alerts based on bispectral index monitoring or minimum alveolar concentration for the prevention of intraoperative awareness

<p>Abstract</p> <p>Background</p> <p>The incidence of intraoperative awareness with explicit recall is 1-2/1000 cases in the United States. The Bispectral Index monitor is an electroencephalographic method of assessing anesthetic depth that has been shown in one prospective study to reduce the incidence of awareness in the high-risk population. In the B-Aware trial, the number needed to treat in order to prevent one case of awareness in the high-risk population was 138. Since the number needed to treat and the associated cost of treatment would be much higher in the general population, the efficacy of the Bispectral Index monitor in preventing awareness in all anesthetized patients needs to be clearly established. This is especially true given the findings of the B-Unaware trial, which demonstrated no significant difference between protocols based on the Bispectral Index monitor or minimum alveolar concentration for the reduction of awareness in high risk patients.</p> <p>Methods/Design</p> <p>To evaluate efficacy in the general population, we are conducting a prospective, randomized, controlled trial comparing the Bispectral Index monitor to a non-electroencephalographic gauge of anesthetic depth. The total recruitment for the study is targeted for 30,000 patients at both low and high risk for awareness. We have developed a novel algorithm that is capable of real-time analysis of our electronic perioperative information system. In one arm of the study, anesthesia providers will receive an electronic page if the Bispectral Index value is >60. In the other arm of the study, anesthesia providers will receive a page if the age-adjusted minimum alveolar concentration is <0.5. Our minimum alveolar concentration algorithm is sensitive to both inhalational anesthetics and intravenous sedative-hypnotic agents.</p> <p>Discussion</p> <p>Awareness during general anesthesia is a persistent problem and the role of the Bispectral Index monitor in its prevention is still unclear. The Michigan Awareness Control Study is the largest prospective trial of awareness prevention ever conducted.</p> <p>Trial Registration</p> <p>Clinical Trial NCT00689091</p

A novel system for automated propofol sedation: hybrid sedation system (HSS)

Closed-loop systems for propofol have been demonstrated to be safe and reliable for general anesthesia. However, no study has been conducted using a closed-loop system specifically designed for sedation in patients under spinal anesthesia. We developed an automatic anesthesia sedation system that allows for closed-loop delivery of propofol for sedation integrating a decision support system, called the hybrid sedation system (HSS). The objective of this study is to compare this system with standard practice. One hundred fifty patients were enrolled and randomly assigned to two groups: HSS-Group (N = 75), in which propofol was administered using a closed-loop system; Control Group (N = 75), in which propofol was delivered manually. The clinical performance of the propofol sedation control is defined as efficacy to maintain bispectral index (BIS) near 65. The clinical control was called ‘Excellent’, ‘Good’, ‘Poor’ and ‘Inadequate’ with BIS values within 10 %, from 11 to 20 %, 21 to 30 %, or greater than 30 % of the BIS target of 65, respectively. The controller performance was evaluated using Varvel’s parameters. Data are presented as mean ± standard deviation, groups were compared using t test or Chi square test, P &lt; 0.05. Clinical performance of sedation showed ‘Excellent’ control in the HSS-group for a significantly longer period of time (49 vs. 26 % in the control group, P &lt; 0.0001). ‘Poor’ and ‘Inadequate’ sedation was significantly shorter in the HSS Group compared to the Control Group (11 and 10 % vs. 20 and 18 %, respectively, P &lt; 0.0001). The novel, closed-loop system for propofol sedation showed better maintenance of the target BIS value compared to manual administration

First genomic study on Lake Tanganyika sprat Stolothrissa tanganicae : a lack of population structure calls for integrated management of this important fisheries target species

BackgroundClupeid fisheries in Lake Tanganyika (East Africa) provide food for millions of people in one of the world's poorest regions. Due to climate change and overfishing, the clupeid stocks of Lake Tanganyika are declining. We investigate the population structure of the Lake Tanganyika sprat Stolothrissa tanganicae, using for the first time a genomic approach on this species. This is an important step towards knowing if the species should be managed separately or as a single stock. Population structure is important for fisheries management, yet understudied for many African freshwater species. We hypothesize that distinct stocks of S. tanganicae could be present due to the large size of the lake (isolation by distance), limnological variation (adaptive evolution), or past separation of the lake (historical subdivision). On the other hand, high mobility of the species and lack of obvious migration barriers might have resulted in a homogenous population.ResultsWe performed a population genetic study on wild-caught S. tanganicae through a combination of mitochondrial genotyping (96 individuals) and RAD sequencing (83 individuals). Samples were collected at five locations along a north-south axis of Lake Tanganyika. The mtDNA data had low global FST and, visualised in a haplotype network, did not show phylogeographic structure. RAD sequencing yielded a panel of 3504 SNPs, with low genetic differentiation (F-ST=0.0054; 95% CI: 0.0046-0.0066). PCoA, fineRADstructure and global F-ST suggest a near-panmictic population. Two distinct groups are apparent in these analyses (F-ST=0.1338 95% CI: 0.1239,0.1445), which do not correspond to sampling locations. Autocorrelation analysis showed a slight increase in genetic difference with increasing distance. No outlier loci were detected in the RADseq data.ConclusionOur results show at most very weak geographical structuring of the stock and do not provide evidence for genetic adaptation to historical or environmental differences over a north-south axis. Based on these results, we advise to manage the stock as one population, integrating one management strategy over the four riparian countries. These results are a first comprehensive study on the population structure of these important fisheries target species, and can guide fisheries management.Peer reviewe

Variant analysis from bacterial isolates affirms DnaK crucial for multidrug resistance

Next-generation sequencing and associated computational analyses have become powerful tools for comparing the whole genomes and detecting the single nucleotide polymorphisms (SNPs) within the genes. In our study, we have identified specific mutations within the plausible drug resistant genes of eight multidrug resistant (MDR) bacterial species. Essentially, we have unearthed few proteins, involved in folding and enabling survival under stress, to be the most crucial ones from the network of the whole genome protein interactome (PIN) of these species. To confirm the relevance of these proteins to antibiotic resistance, variant analyses were performed on all the selected MDR species, isolated from patients’ samples in PATRIC database, against their respective reference genomes. The SNPs found in the patient isolates revealed the nucleotide changes from C to A on DnaK, thereby altering a single amino acid change that might lead to misfolding of proteins. Thus, we propose DnaK to be the best characterized bacterial chaperone having implications in multidrug resistance. To this end, to provide an alternative solution to tackle MDR, docking studies were performed with a phenaleno-furanone derivative which revealed the highest binding energy and inhibition against DnaK