Protocol for the BAG-RECALL clinical trial: a prospective, multi-center, randomized, controlled trial to determine whether a bispectral index-guided protocol is superior to an anesthesia gas-guided protocol in reducing intraoperative awareness with explicit recall in high risk surgical patients

<p>Abstract</p> <p>Background</p> <p>Awareness with explicit recall of intra-operative events is a rare and distressing complication that may lead to severe psychological symptoms. Candidate depth of anesthesia monitors have been developed, partly with the aim of preventing this complication. Despite conflicting results from clinical trials and the lack of incisive validation, such monitors have enjoyed widespread clinical adoption, in particular the bispectral index. The American Society of Anesthesiologists has called for adequately powered and rigorously designed clinical trials to determine whether the use of such monitors decreases the incidence of awareness in various settings. The aim of this study is to determine with increased precision whether incorporating the bispectral index into a structured general anesthesia protocol decreases the incidence of awareness with explicit recall among a subset of surgical patients at increased risk for awareness and scheduled to receive an inhalation gas-based general anesthetic.</p> <p>Methods/Design</p> <p>BAG-RECALL is a multi-center, randomized, controlled clinical trial, in which 6,000 patients are being assigned to bispectral index-guided anesthesia (target range, 40 to 60) or end-tidal anesthetic gas-guided anesthesia (target range, 0.7 to 1.3 age-adjusted minimum alveolar concentration). Postoperatively, patients are being assessed for explicit recall at two intervals (0 to 72 hours, and 30 days after extubation). The primary outcome of the trial is awareness with explicit recall. Secondary outcomes include postoperative mortality, psychological symptoms, intensive care and hospital length of stay, average anesthetic gas administration, postoperative pain and nausea and vomiting, duration of stay in the recovery area, intra-operative dreaming, and postoperative delirium.</p> <p>Discussion</p> <p>This trial has been designed to complement two other clinical trials: B-Unaware and MACS (ClinicalTrials.gov numbers, NCT00281489 and NCT00689091). With the large patient numbers and complementary rigorous designs, it is envisaged that pre-specified meta-analyses will address some of the outstanding controversies and questions relating to processed electroencephalography monitoring.</p> <p>Trial registration</p> <p>ClinicalTrials.gov Identifier: NCT00682825</p

Monitoring the Depth of Anaesthesia

One of the current challenges in medicine is monitoring the patients’ depth of general anaesthesia (DGA). Accurate assessment of the depth of anaesthesia contributes to tailoring drug administration to the individual patient, thus preventing awareness or excessive anaesthetic depth and improving patients’ outcomes. In the past decade, there has been a significant increase in the number of studies on the development, comparison and validation of commercial devices that estimate the DGA by analyzing electrical activity of the brain (i.e., evoked potentials or brain waves). In this paper we review the most frequently used sensors and mathematical methods for monitoring the DGA, their validation in clinical practice and discuss the central question of whether these approaches can, compared to other conventional methods, reduce the risk of patient awareness during surgical procedures

Parent Child Development Center (PCDC) follow-up : parent, teacher, and self-report of Mexican American adolescent behavior problems

A follow-up of the Parent Child Development Center (PCDC) study examined the reports of behavior problems for Mexican American adolescents from mothers, teachers and the adolescents. The 109 Mexican American families, 75 control group and 34 program group representing four cohorts, were randomly assigned when the index children were one year of age. Data were collected in the homes of the mothers and index children, ages 10-14, and from their teachers at school. The program and control groups, raters, and both sexes were compared on three measures, the Child Behavior Checklist (Achenbach & Edelbrock, 1981), completed by mothers, the Youth Self-Report (Achenbach & Edelbrock, 1983) , completed by the adolescents, and the AML (Cowen et al., 1973), completed by the teachers. All instruments reported internalizing, externalizing and total T scores. It was found that self-report contained more internalizing behaviors than parent and teacher reports, through a Multivariate Analysis of Variance, F(1,108) = 5.87, p < .017. No group differences were found for behavior problems. Post-hoc analyses found that group differences were due to the perspective of the rater, rather than the sex of the index child, or the type of behavior being rated. Suggestions were offered that future studies on behavior problems from multiple perspectives separate method variance from trait variance.Psychology, Department o

Virtual Reality for Pediatric Anesthesia

The 2017 Translational Medicine Symposium was held on Feb. 27th. The symposium addressed how clinicians' ideas and research results can have an impact on patient care - if they are translated into clinical practice. The symposium was a collaboration of the Entrepreneurial Faculty Scholars (EFS) program, led by Dr. Glenn D. Prestwich, the HHMI Med to Grad program (U2M2G), co-directed by Drs. Anthea Letsou and Dean Li, and the Center for Medical Innovation. Intended as a great opportunity for faculty, students, and postgraduate entrepreneurs to get acquainted with the complex and non-linear process of translating medical devices, diagnostics, therapeutics, digital health applications, and research tools so they can be used to impact patient care. Clinician innovators and entrepreneurs shared their experiences and a panel of experts discussed opportunities, barriers, and steps in creating impactful healthcare innovations

Virtual Reality for Pediatric Anesthesia

The 2017 Translational Medicine Symposium was held on Feb. 27th. The symposium addressed how clinicians' ideas and research results can have an impact on patient care - if they are translated into clinical practice. The symposium was a collaboration of the Entrepreneurial Faculty Scholars (EFS) program, led by Dr. Glenn D. Prestwich, the HHMI Med to Grad program (U2M2G), co-directed by Drs. Anthea Letsou and Dean Li, and the Center for Medical Innovation. Intended as a great opportunity for faculty, students, and postgraduate entrepreneurs to get acquainted with the complex and non-linear process of translating medical devices, diagnostics, therapeutics, digital health applications, and research tools so they can be used to impact patient care. Clinician innovators and entrepreneurs shared their experiences and a panel of experts discussed opportunities, barriers, and steps in creating impactful healthcare innovations