Immediate cooling of the brain during the resuscitation period by the use of a pharyngeal cooling device

UMIN ID: UMIN000002224

Registered date:31/07/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Witnessed cardiac arrest(except cardiac arrest due to trauma)
• Date of first enrollment: 2009/06/01
• Target sample size: 300
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Patients in the treatment group will undergo 2 hours of pharyngeal cooling during resuscitation or early after recovery of spontaneous circulation.
Patients in the control group will not undergo pharyngeal cooling during or after resuscitation.

Outcome(s)

• Primary Outcome: Time until tympanic temperature decreases by 1.0 degrees centigrade. Glasgow Coma Scale at 2 weeks after resuscitation Glasgow Pittsburgh cerebral performance and overall performance categories at 1 month and 6 months after resuscitation Mortality rates at 1 month and 6 months after resuscitation

Key inclusion & exclusion criteria

• Age minimum: 16years-old
• Age maximum: 89years-old
• Gender: Male and Female
• Exclude criteria: 1. Patients with a disorder in the pharynx or esophagus. 2. Patients with severe hypothermia (less than 34 degrees centigrade upon arrival). 3. Patients who are pregnant. 4. Patients with an immunodeficiency or medicated with an immunosuppressant. 5. Patients with brain damage initiated by a mechanism other than cardiac arrest. 6. Rejection by a person in parental authority. 7. Score of Barthel index of less than 66.

Related Information

• Primary Sponsor: Okayama University Medical School
• Source(s) of Monetary Support: Ministry of Health, Labor and Welfare