Anesthesiology Commons^™

Application Of Incident Command Structure To Clinical Trial Management In The Academic Setting: Principles And Lessons Learned, Penny S. Reynolds, Mary J. Michael, Bruce D. Spiess

Anesthesiology Publications

Background

Clinical trial success depends on appropriate management, but practical guidance to trial organisation and planning is lacking. The Incident Command System (ICS) is the ‘gold standard’ management system developed for managing diverse operations in major incident and public health arenas. It enables effective and flexible management through integration of personnel, procedures, resources, and communications within a common hierarchical organisational structure. Conventional ICS organisation consists of five function modules: Command, Planning, Operations, Logistics, and Finance/Administration. Large clinical trials will require a separate Regulatory Administrative arm, and an Information arm, consisting of dedicated data management and information technology staff. We applied …

Prehospital Use Of Plasma In Traumatic Hemorrhage (The Pupth Trial): Study Protocol For A Randomised Controlled Trial, Penny S. Reynolds, Mary Jane Michael, Emily D. Cochran, Jacob A. Wegelin, Bruce D. Spiess

Anesthesiology Publications

Background

Severe traumatic injury and haemorrhagic shock are frequently associated with disruptions of coagulation function (such as trauma-induced coagulopathy TIC) and activation of inflammatory cascades. These pathologies may be exacerbated by current standard of care resuscitation protocols. Observational studies suggest early administration of plasma to severely-injured haemorrhaging patients may correct TIC, minimise inflammation, and improve survival. The proposed randomised clinical trial will evaluate the clinical effectiveness of pre-hospital plasma administration compared with standard- of-care crystalloid resuscitation in severely-injured patients with major traumatic haemorrhage.

Methods/design

This is a prospective, randomized, open-label, non-blinded trial to determine the effect of pre-hospital administration of …

Lactate Versus Non-Lactate Metabolic Acidosis: A Retrospective Outcome Evaluation Of Critically Ill Patients, Kyle J. Gunnerson, Melissa Saul, Shui He, John A. Kellum

Anesthesiology Publications

Introduction

Acid–base abnormalities are common in the intensive care unit (ICU). Differences in outcome exist between respiratory and metabolic acidosis in similar pH ranges. Some forms of metabolic acidosis (for example, lactate) seem to have worse outcomes than others (for example, chloride). The relative incidence of each type of disorder is unknown. We therefore designed this study to determine the nature and clinical significance of metabolic acidosis in critically ill patients.

Methods

An observational, cohort study of critically ill patients was performed in a tertiary care hospital. Critically ill patients were selected on the clinical suspicion of the presence of …

The Impact Of An Hematocrit Of 20% During Normothermic Cardiopulmonary Bypass For Elective Low Risk Coronary Artery Bypass Graft Surgery On Oxygen Delivery And Clinical Outcome – A Randomized Controlled Study [Isrctn35655335], Christian Von Heymann, Michael Sander, Achim Foer, Anja Heinemann, Bruce Spiess, Jan Braun, Michael Krämer, Joachim Grosse, Pascal Dohmen, Simon Dushe, Jürgen Halle, Wolfgang F. Konertz, Klaus-Dieter Warnecke, Claudia Spies

Anesthesiology Publications

Introduction

Cardiopulmonary bypass (CPB) induces hemodilutional anemia, which frequently requires the transfusion of blood products. The objective of this study was to evaluate oxygen delivery and consumption and clinical outcome in low risk patients who were allocated to an hematocrit (Hct) of 20% versus 25% during normothermic CPB for elective coronary artery bypass graft (CABG) surgery.

Methods

This study was a prospective, randomized and controlled trial. Patients were subjected to normothermic CPB (35 to 36°C) and were observed until discharge from the intensive care unit (ICU). Outcome measures were calculated whole body oxygen delivery, oxygen consumption and clinical outcome. A …

Adverse Cerebral Outcomes After Coronary Bypass Surgery, Gary W. Roach , M.D., Marc Kanchuger , M.D., Christina Mora Mangano , M.D., Mark Newman , M.D., Nancy Nussmeier , M.D., Richard Wolman , M.D., Anil Aggarwal , M.D., Katherine Marschall , M.D., Steven H. Graham , M.D., Ph.D., Catherine Ley , Ph.D., Gerard Ozanne , M.D., Dennis T. Mangano , Ph.D., M.D., Ahvie Herskowitz , M.D., Vera Katseva , Ph.D, Rita Sears , R.N., M.S.

Anesthesiology Publications

ABSTRACT

Background Acute changes in cerebral function after elective coronary bypass surgery are a difficult clinical problem. We carried out a multicenter study to determine the incidence and predictors of — and the use of resources associated with — perioperative adverse neurologic events, including cerebral injury.

Methods In a prospective study, we evaluated 2108 patients from 24 U.S. institutions for two general categories of neurologic outcome: type I (focal injury, or stupor or coma at discharge) and type II (deterioration in intellectual function, memory deficit, or seizures).

Results Adverse cerebral outcomes occurred in 129 patients (6.1 percent). A total of …