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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002224
Enrollment
300
Registered
2009-07-31
Start date
2009-06-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Witnessed cardiac arrest(except cardiac arrest due to trauma)

Interventions

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 phary

Sponsors

Okayama University Medical School
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with witnessed cardiogenic cardiac arrest or witnessed non-cardiogenic cardiac arrest except posttraumatic cardiac arrest. 2. Patients who have been resuscitated by medical services within 15 min after the onset of cardiac arrest.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactYoshimasa Takeda, MD, PhD

Okayama University Medical School Anesthesiology & Resuscitology

yoshit@cc.okayama-u.ac.jp81-86-235-7778

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026