SETPOINT 2

Stroke-Related Early Tracheostomy versus Prolonged Orotracheal Intubation in Neurocritical care Trial 2 

Laufzeit: 2015 - 2018

Leiter der klinischen Prüfung: PD Dr. J. Bösel (Neurologie Heidelberg)

Beteiligte des IMBI: Prof. Dr. M. Kieser, K. Kunzmann, C. Klose

Projektbeschreibung

Ischemic and hemorrhagic stroke is frequent disease (e.g. affects about 700,000 Americans annually), and when stroke is accompanied by respiratory failure, outcomes historically have been poor]. Because these patients may have prolonged coma or failed airway protective reflexes, they are at high risk of pulmonary aspiration, and often remain intubated for prolonged periods of time despite adequate cardiopulmonary function. Early tracheostomy in such patients may potentially result in shorter duration of mechanical ventilation, decreased sedation and analgesic administration, shorter time to “wake-up” and participation in rehab activities, lower incidence of pneumonia, improved survival and functional outcomes, and decreased cost of care.

SETPOINT 2 is a randomized, assessor-blinded Phase III clinical trial of early tracheostomy vs. prolonged intubation and ventilator weaning for respiratory support of patients with severe ischemic and hemorrhagic strokes. The primary aim of the trial is to test for advantageous functional long-term outcome by early tracheostomy, secondary aims are to test for advantages in the ICU course of these patients, including cost of treatment. The trial is a joint venture of the United States Neurocritical Care Society Research Network (NCSRN) and the research network Initiative for German Neuro Intensive Trial Engagement (IGNITE) of the German Neurocritical Care Society (DGNI).

Publikationen

Schönenberger S., Niesen W. D., Fuhrer H., Bauza C., Klose C., Kieser M., Suarez J., Seder D., Bösel J. (2015): Early tracheostomy in ventilated stroke patients: Study protocol of the international multicentre randomized trial SETPOINT2 (Strokerelated Early Tracheotomy vs. Prolonged Orotracheal Intubation in Neurocritical care Trial 2). Akzeptiert bei International Journal of Stroke

MODERNISE

Laufzeit: 2015 - 2018

Leiter der klinischen Prüfung: PD Dr. J. Bösel (Neurologie Heidelberg), Dr. A. Rabinstein (Neurology, Mayo Clinic, Rochester)

Beteiligte des IMBI: Prof. Dr. M. Kieser, L. Uhlmann, C. Klose

Projektbeschreibung

While sedation policy has shifted from deep sedation to moderate, minimal, or even no sedation in the general ICU, optimal sedation of the cerebrovascular NICU patient is unclear and controversial. The rationale of this study is to analyze potential benefits, feasibility and safety of moderate as opposed to deep sedation.

MODERNISE is a pilot trial aiming to investigate the safety, feasibility and potential benefits of moderate vs. deep sedation in patients with severe ischemic stroke, intracerebral hemorrhage or subarachnoid hemorrhage. The primary objective is to compare moderate sedation and deep sedation with respect to ICU-LOS.