Daniel Grassmann

Reduction of Serious Adverse Events Demanding Study Exclusion in Model Development: Extracorporeal Life Support Resuscitation of Ventricular Fibrillation Cardiac Arrest in Rats

ABSTRACT Extracorporeal life support is a promising concept for selected patients in refractory cardiogenic shock and for advanced life support of persistent ventricular fibrillation cardiac arrest. Animal models of ventricular fibrillation cardiac arrest could help to investigate new treatment strategies for successful resuscitation. Associated procedural pitfalls in establishing a rat model of extracorporeal life support resuscitation need to be replaced, refined, reduced, and reported. Anesthetized male Sprague-Dawley rats (350–600 g) (n = 126) underwent cardiac arrest induced with a pacing catheter placed into the right ventricle via a jugular cannula. Rats were resuscitated with extracorporeal life support, mechanical ventilation, defibrillation, and medication. Catheter and cannula explantation was performed if restoration of spontaneous circulation was achieved. All observed serious adverse events (SAEs) occurring in each of the experimental phases were analyzed. Restoration of spontaneous circulation could be achieved in 68 of 126 rats (54%); SAEs were observed in 76 (60%) experiments. Experimental procedures related SAEs were 62 (82%) and avoidable human errors were 14 (18%). The most common serious adverse events were caused by insertion or explantation of the venous bypass cannula and resulted in lethal bleeding, cannula dislocation, or air embolism. Establishing an extracorporeal life support model in rats has confronted us with technical challenges. Even advancements in small animal critical care management over the years delivered by an experienced team and technical modifications were not able to totally avoid such serious adverse events. Replacement, refinement, and reduction reports of serious adverse events demanding study exclusions to avoid animal resources are missing and are presented hereby.

Surveillance of Patients in the Waiting Area of the Department of Emergency Medicine.

AbstractMany patients visiting an emergency department are in reduced general condition of health and at risk of suffering further deterioration during their stay. We wanted to test the feasibility of a new monitoring system in a waiting area of an emergency department.In an observational cross-sectional single-center study, patients with acute cardiac or pulmonary symptoms or in potentially life-threatening conditions were enrolled. Monitoring devices providing vital signs via short range radio (SRR) at certain time points and compliance evaluation forms were used.Out of 230 patients, 4 wanted to terminate their participation prematurely. No data was lost due to technical difficulties. Over a median monitoring period of 178 (118–258) min per patient, 684 h of vital sign data were collected and used to assist managing those patients. Linear regression analysis between clinical symptom category groups of patients showed significant differences in the respiratory rate and noninvasive blood pressure courses. Feedback from patients and users via questionnaires showed overall very good acceptance and patients felt that they were given better care.To assist medical staff of an emergency department waiting area to rapidly response to potentially life-threatening situations of its patients, a new monitoring system proved to be feasible and safe.