Unique ID issued by UMIN | UMIN000008506 |
---|---|
Receipt number | R000009995 |
Scientific Title | Effect of pharyngeal cooling during the resuscitation period on life prognosis |
Date of disclosure of the study information | 2012/08/01 |
Last modified on | 2014/02/19 12:28:29 |
Effect of pharyngeal cooling during the resuscitation period on life prognosis
i-cool 2
Effect of pharyngeal cooling during the resuscitation period on life prognosis
i-cool 2
Japan |
Witnessed cardiac arrest(except cardiac arrest due to trauma)
Cardiology | Neurology | Anesthesiology |
Neurosurgery | Emergency medicine | Intensive care medicine |
Others
NO
This study was designed to elucidate the effects of pharyngeal cooling initiated during or immediately after resuscitation on mortality rate.
Safety,Efficacy
Confirmatory
Mortality rates at 1 month, 3 months and 6 months after resuscitation
Time until tympanic temperature reaches 32.0 degrees centigrade after arrival at the hospital.
Glasgow Coma Scale at 2 weeks after resuscitation
Glasgow Pittsburgh cerebral performance and overall performance categories at 1 month and 6 months after resuscitation
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
NO
NO
Institution is considered as a block.
YES
Central registration
2
Treatment
Device,equipment |
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 undergo standard treatment but will not undergo pharyngeal cooling during or after resuscitation.
16 | years-old | <= |
89 | years-old | >= |
Male and Female
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.
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.
692
1st name | |
Middle name | |
Last name | Kiyoshi Morita, MD, PhD |
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical
Functional Physiology
2-5-1 Shikata-cho Kitaku Okayama
81-86-235-7778
yoshit@cc.okayama-u.ac.jp
1st name | |
Middle name | |
Last name | Yoshimasa Takeda, MD, PhD |
Okayama University Medical School
Anesthesiology
2-5-1 Shikata-cho Kitaku Okayama
81-86-235-7778
http://www.cc.okayama-u.ac.jp/~cool/index.html
yoshit@cc.okayama-u.ac.jp
Okayama University Medical School
Daiken Medical Co.
Profit organization
Japan
NO
岡山大学病院 高度救命救急センター(岡山県)、津山中央病院 救命救急センター(岡山県)、神戸大学医学部附属病院 救急部(兵庫県)、さいたま赤十字病院 救命救急センター(埼玉県)、大阪府立急性期・総合医療センター 救命救急センター(大阪府)、千葉大学医学部附属病院 救急部・集中治療部(千葉県)、北九州総合病院 救命救急センター(福岡県)、大阪府三島救命救急センター(大阪府)、熊本赤十字病院 救命救急センター(熊本県)、呉共済病院 救急診療科(広島県)、岡崎市民病院 救命救急センター(愛知県)、北里大学病院 救命救急センター(神奈川県)、日本大学医学部附属板橋病院 救命救急センター(東京都)、姫路医療センター 救急診療科(兵庫県)、香川労災病院 救急部(香川県)、東邦大学医療センター大森病院 救命救急センター(東京都)、帝京大学医学部附属病院(東京都)、熊本医療センター 救命救急センター(熊本県)、広島大学病院高度救命救急センター(広島県)、名古屋市立大学病院(愛知県)
2012 | Year | 08 | Month | 01 | Day |
Unpublished
Completed
2011 | Year | 12 | Month | 01 | Day |
2011 | Year | 12 | Month | 01 | Day |
2012 | Year | 07 | Month | 23 | Day |
2014 | Year | 02 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009995
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |