Contact information
Type
Scientific
Primary contact
Dr Yoshimasa Takeda
ORCID ID
Contact details
Okayama University Hospital
Department of Anesthesiology and Resuscitation
2-5-1 Shikata-Cho
Okayama
700-8558
Japan
yoshit@cc.okayama-u.ac.jp
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
UMIN000002224
Study information
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
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.
Ethics approval
Okayama University Ethics Committee approved on the 4th February 2009 (ref: 620)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Brain hypothermia
Intervention
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.
Intervention type
Device
Phase
Not Applicable
Drug names
Primary outcome measures
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 measures
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
Overall trial start date
01/06/2009
Overall trial end date
31/03/2010
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
300
Participant 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
Recruitment start date
01/06/2009
Recruitment end date
31/03/2010
Locations
Countries of recruitment
Japan
Trial participating centre
Okayama University Hospital
Okayama
700-8558
Japan
Sponsor information
Organisation
Okayama University (Japan)
Sponsor details
c/o Yoshimasa Takeda
Okayama University Hospital
Department of Anesthesiology and Resuscitation
2-5-1 Shikata-Cho
Okayama
700-8558
Japan
yoshit@cc.okayama-u.ac.jp
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Ministry of Health, Labor and Welfare (Japan) (ref: H19- Trans- General-005)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary