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Immediate cooling of the brain during the resuscitation period by the use of a pharyngeal cooling device
ISRCTN ISRCTN98089900
DOI 10.1186/ISRCTN98089900
ClinicalTrials.gov identifier
EudraCT number
Public title Immediate cooling of the brain during the resuscitation period by the use of a pharyngeal cooling device
Scientific title Immediate cooling of the brain during the resuscitation period by the use of a pharyngeal cooling device: a randomised controlled trial
Acronym i-Cool
Serial number at source UMIN000002224
Study hypothesis This study was designed to elucidate the effects of pharyngeal cooling initiated during or immediately after resuscitation on tympanic temperature, neurological recovery and mortality rate.
Lay summary
Ethics approval Okayama University Ethics Committee approved on the 4th February 2009 (ref: 620)
Study design Randomised controlled trial
Countries of recruitment Japan
Disease/condition/study domain Brain hypothermia
Participants - 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
Participants - 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
Anticipated start date 01/06/2009
Anticipated end date 31/03/2010
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 300
Interventions Methods used for resuscitation will comply with AHA Guidelines (2005).

Treatment group:
Immediately after tracheal intubation, the pharyngeal cooling cuff will be inserted and pharyngeal cooling will be initiated. Otherwise, the treatment procedures conventionally performed at the medical facility will be conducted. Required procedures of pharyngeal cooling:
1. Rate of perfusion: 500 mL/min
2. Perfusion pressure: 50 - 20 cm H2O
3. Perfusate: Physiological saline (5°C)
4. Target tympanic membrane temperature: 32°C
5. Cooling duration: 2 hours
Conditions for ending treatment:
1. When spontaneous circulation does not return and resuscitation measures have been discontinued
2. When pharyngeal cooling has been performed for greater than 2 hours

Control group:
Treatment conventionally performed at the medical facility will be conducted.
Primary outcome measure(s) 1. Lowest tympanic membrane temperature within 2 hours of start of pharyngeal cooling
2. Time until tympanic temperature decreases by 1.0°C
Secondary outcome measure(s) 1. Functional prognosis:
1.1. Evaluation of level of consciousness: Glasgow Coma Scale 2 weeks after resuscitation
1.2. Evaluation of neurological function: Glasgow Pittsburgh Cerebral Performance categories evaluated 1 and 6 months after resuscitation
2. Life prognosis:
2.1. Return of spontaneous circulation (ROSC); ROSC defined as a return of palpable pulse: ROSC time, rate of ROSC
2.2. Mortality rate: Mortality rates at 1, 3, and 6 months after resuscitation
3. Incidence rate of complications during 3-day period after start of resuscitation: acute lung injury, systemic inflammatory response syndrome, sepsis, dialysis, pericutaneous cardiopulmonary support, thrombocytopenia, coagulopathy, arrhythmia
4. Subgroup analysis: Evaluation of effect of cooling, functional prognosis, and life prognosis, based on as-treated analysis in compliance with the protocol, such as pharyngeal cooling time
5. Subgroup analysis: Evaluation of functional prognosis and life prognosis of subgroups of patients surviving 6 hours and 24 hours
6. Subgroup analysis: Effect of cooling, and evaluation of functional prognosis and life prognosis, in subgroup of patients who did not undergo pericutaneous cardiopulmonary support or intravenous administration of cold fluids
7. Subgroup analysis: Duration of stay in intensive care and duration of hospital stay, in subgroup of patients who survived
Sources of funding Ministry of Health, Labor and Welfare (Japan) (ref: H19- Trans- General-005)
Trial website
Publications
Contact name Dr  Yoshimasa  Takeda
  Address Okayama University Hospital
Department of Anesthesiology and Resuscitation
2-5-1 Shikata-Cho
  City/town Okayama
  Zip/Postcode 700-8558
  Country Japan
  Email yoshit@cc.okayama-u.ac.jp
Sponsor Okayama University (Japan)
  Address c/o Yoshimasa Takeda
Okayama University Hospital
Department of Anesthesiology and Resuscitation
2-5-1 Shikata-Cho
  City/town Okayama
  Zip/Postcode 700-8558
  Country Japan
  Email yoshit@cc.okayama-u.ac.jp
  Sponsor website: http://www.cc.okayama-u.ac.jp/~cool/index.html
Date applied 23/11/2009
Last edited 10/12/2009
Date ISRCTN assigned 10/12/2009
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