In this clinical trial will be checked, whether 2 hours ventilation with xenon has neuroprotetctive effect on the patients, which had out of hospital cardiac arrest and successful cardiopulmonary resuscitation MedDRA version: 16.1 Level: PT Classification code 10067221 Term: Mechanical ventilation System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Xenon pro Anaesthesia
Product Name: Xenon pro Anaesthesia
Pharmaceutical Form: Inhalation vapour
INN or Proposed INN: XENON (133XE)
CAS Number: 14932-42-4
Concentration unit: % (V/V) perce
Sponsors
Clinical Trials Center Aachen, University of Aachen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with out of hospital cardiac arrest and successeful cardiopulmonary resuscitation, which will be treated with therapeutic hypothermia at Department of Internal Medicine I of Teaching Hospital of Unversity of Aachen 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 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: - Patients younger than 18 years - Xenon allergy - Pregnancy - High inspired oxygen requirement (> 70%) in order to maintain adequate arterial oxygen saturation (SpO2> 94%) at the beginning of treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Feasibility and safety of combined treatment of xenon and therapeutic hypothermia in patients with successfull cardiopulmonary resuscitation after out of hospital cardiac arrest ;Secondary Objective: Influence of combined treatment of xenon and therapeutic hypothermia on neurological outcome , cardiac function and mortality in patients with successfull cardiopulmonary resuscitation after out of hospital cardiac arrest ;Primary end point(s): Safety and efficacy of xenon ventilation within 2 hours after successful cardiopulmonale resuscitation;Timepoint(s) of evaluation of this end point: during 2h of Xenon-Ventilation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Significant difference between treatment group and control group.;Timepoint(s) of evaluation of this end point: within 28 days after cardiac arrest | — |
Countries
Germany
Contacts
Public ContactClinical Trial Center Aachen
University RWTH Aachen
Outcome results
None listed