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

Not Applicable

Completed

• Conditions: Brain hypothermia; Surgery; Other complications of surgical and medical care, not elsewhere classified

• Registration Number: ISRCTN98089900
• Lead Sponsor: Okayama University (Japan)

Brief Summary

2014 results in: https://www.ncbi.nlm.nih.gov/pubmed/25263513 (added 21/08/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-12-10
• Study Completion: 2010-03-31
• Last Update Posted: 9 September 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

1. Patients with witnessed cardiogenic cardiac arrest or witnessed non-cardiogenic cardiac arrest except post-traumatic cardiac arrest
2. Patients who have been resuscitated by medical services within 15 minutes after the onset of cardiac arrest
3. Aged 16 - 89 years old, either sex

Exclusion Criteria

1. Patients with a disorder in the pharynx or oesophagus
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 (except for steroids)
5. Patients with brain damage initiated by a mechanism other than cardiac arrest
6. Rejection by a person in parental authority
7. Barthel Index Score of less than 66

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Lowest tympanic membrane temperature within 2 hours of start of pharyngeal cooling<br> 2. Time until tympanic temperature decreases by 1.0°C<br>