Clinical Study of the LRS ThermoSuit™ System in Post Arrest Patients with Intravenous Infusion of Magnesium Sulfate

ife Recovery Systems0 个研究点开始时间: 2007年10月24日最近更新: 2013年7月15日

适应症

试验速览

暂无简介。

•1.Cardiac arrest prior to or during hospital admission, with restoration/return of spontaneous circulation (ROSC).
•2.Estimated or known age > 18 years.
•3.Intubation, ventilation and placement of esophageal temperature probe.
•4.Persistent neurologic dysfunction i.e. comatose upon enrollment [GCS = 8].
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1.Height greater than 188 cm.
•2.Elbow-to-elbow width greater than 60 cm (as measured above the supine patient).
•3.Core temperature less than 35°C after ROSC (as measured in the esophagus).
•4.Comatose state before the cardiac arrest due to the administration of drugs that depress the central nervous system.
•5.Known pregnancy.
•6.Known terminal illness that preceded the arrest.
•7.Known enrollment in another study of a device, drug, or biologic.
•8.Major trauma or other co-morbidity requiring urgent surgery.
•9.> 4 hours since return of spontaneous circulation.
•10.Severe coagulopathy (with active bleeding).
•11.Hemodynamic instability despite vasopressors (SBP < 90 mmHg or MAP < 60 mmHg for > 30 minutes after ROSC and before enrollment).
•12.Bradycardia (HR<60/min)
•13.Allergy against MgSo4
•14.AV-block
•15.Myasthenia gravis
•16.Known terminal renal insufficiency (creatinine-clearence < 20ml/min)
•17.Severe myocardial dysfunction (EF<25%)
•18.Chronic digitalis therapy

发起方

ife Recovery Systems