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

ISRCTN	ISRCTN98089900
DOI	https://doi.org/10.1186/ISRCTN98089900
Protocol serial number	UMIN000002224
Sponsor	Okayama University (Japan)
Funder	Ministry of Health, Labor and Welfare (Japan) (ref: H19- Trans- General-005)

Submission date: 23/11/2009
Registration date: 10/12/2009
Last edited: 21/08/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Yoshimasa Takeda
Scientific

Okayama University Hospital
Department of Anesthesiology and Resuscitation
2-5-1 Shikata-Cho
Okayama
700-8558
Japan

Email	yoshit@cc.okayama-u.ac.jp

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Immediate cooling of the brain during the resuscitation period by the use of a pharyngeal cooling device: a randomised controlled trial
Study acronym	i-Cool
Study objectives	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(s)	Okayama University Ethics Committee approved on the 4th February 2009 (ref: 620)
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)
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
Key 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
Completion date	31/03/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	300
Total final enrolment	108
Key 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
Key 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
Date of first enrolment	01/06/2009
Date of final enrolment	31/03/2010

Locations

Countries of recruitment

Japan

Study participating centre

Okayama University Hospital

Okayama
700-8558
Japan

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2014	21/08/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

21/08/2019: Publication reference and total final enrolment added.