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

Análisis de datos y verificación de componentes eléctricos para clientes de automoción mediante un microcontrolador

En aquest projecte, s'expliquen els passos que cal seguir a l'hora de poder analitzar els components d'automoció fabricats per l'empresa KOSTAL Electric S.A., de la manera més eficient possible, mitjançant el microcontrolador Arduino Due. Els objectius principals d'aquest projecte són desbloquejar, mitjançant programari, el potencial suficient del microcontrolador Arduino Due per satisfer els requisits mínims de l'empresa, per poder rebre i enviar dades a una velocitat fluida. També es procedirà, mitjançant programari, a realitzar una seqüència de connectivitat entre les peces d'automoció fabricades a KOSTAL Electric S.A. i l'aplicació TestMan (aplicació creada per la mateixa empresa), tenint la placa Arduino Due com a intermediari.En el presente proyecto, se explican los pasos a seguir a la hora de poder analizar los componentes de automoción fabricados por la empresa KOSTAL Electric S.A., de la forma más eficiente posible, mediante el microcontrolador Arduino Due. Los objetivos principales de este proyecto son desbloquear, mediante software, el suficiente potencial del microcontrolador Arduino Due para satisfacer los requisitos mínimos de la empresa, para así poder recibir y enviar datos a una velocidad fluida. También se procederá, mediante software, a realizar una secuencia de conectividad entre las piezas de automoción fabricadas en KOSTAL Electric S.A. y la aplicación TestMan (aplicación creada por la propia empresa), teniendo la placa Arduino Due como intermediario. Las partes del proyecto que más relevancia se tienen en cuenta son el entendimiento del microcontrolador del Arduino Due, así como las partes que la forman, el ajuste por software del microcontrolador Arduino Due para aumentar la velocidad de procesado y de la comunicación con las piezas de automoción y la aplicación TestMan, para poder ejecutar sus respectivos análisis. Al diseño final, se le han realizado las pruebas pertinentes para poder validar el correcto funcionamiento en la lectura y envío de datos, así como, la obtención de la velocidad de procesado del Arduino Due, después de su configuración.This project explains the steps to follow in order to analyze the automotive components manufactured by the company KOSTAL Electric S.A., in the most efficient way possible, using the Arduino Due microcontroller. The main objectives of this project are to unlock, through software, the sufficient potential of the Arduino Due microcontroller to meet the minimum requirements of the company, in order to be able to receive and send data at a fluid speed. We will also proceed, by means of software, to perform a connectivity sequence between the automotive parts manufactured at KOSTAL Electric S.A. and the TestMan application (application created by the company itself), having the Arduino Due board as an intermediary

Relationship between bispectral index values and volatile anesthetic concentrations during the maintenance phase of anesthesia in the B-Unaware trial

Hypnotic depth during anesthesia affects electroencephalography waveforms and electroencephalogram-derived indices, such as the bispectral index (BIS). Titrating anesthetic administration against the BIS assumes reliable relationships between BIS values, electroencephalogram waveforms, and effect site concentration, beyond loss of responsiveness. Associations among BIS, end-tidal anesthetic concentrations (ETAC), and patient characteristics were examined during anesthetic maintenance, using B-Unaware trial data