Selective Cerebral Hypothermia Trial - Under Extracorporeal Cardiopulmonary Resuscitation (SHOT-ECPR)

Launched by NATIONAL TAIWAN UNIVERSITY HOSPITAL · Nov 16, 2017

Keywords

ClinConnect Summary

Patients with OHCA and meeting the criteria for initiating extracorporeal membrane oxygenation (ECMO) criteria will be checked for eligibility for the study during CPR by the emergency physicians or staff at the scene. Informed consent will be asked as well. The standard V-A circuit for ECMO will be applied to the patients as soon as they arriving ER following the standard operation procedure of the hospital. The necessary testing and procedures will be applied to check the eligibility of the patients. Eligible subjects and/or their legal representatives will be further confirmed for the co...

Gender

ALL

Eligibility criteria

• Main inclusion criteria:
• Patients are eligible for inclusion in this study, if they fulfil all of the following criteria:
• • 1. Clinical symptoms and signs compatible with OHCA.
• • 2. Age between 20-65 years.
• • 3. Eligible for initiating ECMO criteria.
• • 4. No flow period less than 10 minutes.
• • 5. CPR for longer than 10 minutes without return of spontaneous circulation (ROSC) under active CPR
• • 6. Unconsciousness. Glasgow Coma Scale (GCS) 7T and M4 with tracheal tube 30 minutes after ECMO setup.
• • 7. The ECMO flow can be maintained stable and return of spontaneous beating after ECMO setup for 2 hours.
• • 8. The blood pressure can be maintained with mean pressure around 55 mmHg for 2 hours.
• • 9. Patient or patient's legal representatives is willing to provide the signed informed consent.
• • 10. Able to provide signed informed consent form (ICF) within 6 hours after the event and proceed to selective cerebral hypothermia within 12 hours after the event.
• Main exclusion criteria:
• Patients with any of the following characteristics must not be included in the study:
• • 1. ROSC for 20 minutes after resuscitation without repeated collapse
• • 2. Terminal stage malignancy
• • 3. Pre-existing multi-organ dysfunction
• • 4. Ventilator-dependent \> 3 months
• • 5. Bed-ridden \> 3 months, not self-independent before CPR
• • 6. Traumatic origin, uncontrollable bleeding
• • 7. Patients with cerebral aneurysm
• • 8. Patients with sepsis (blood culture positive)
• • 9. Pregnancy
• • 10. CT scan evidence of cerebral hemorrhage or non-ischemic etiology of neurologic symptoms
• • 11. Severe, untreatable aortoiliac disease or small-caliber iliac arteries restricting vascular access with a 14 French sheath
• • 12. Patients with either side common or internal carotid arteries \>50% stenosis and cannot be worked around
• • 13. Patient with "DNR" order