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 |
| Secondary identifying numbers | UMIN000002224 |
- 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
Scientific
Okayama University Hospital
Department of Anesthesiology and Resuscitation
2-5-1 Shikata-Cho
Okayama
700-8558
Japan
| yoshit@cc.okayama-u.ac.jp |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 study start date | 01/06/2009 |
| Completion date | 31/03/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
700-8558
Japan
Sponsor information
Okayama University (Japan)
University/education
University/education
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 | |
| Website | http://www.cc.okayama-u.ac.jp/~cool/index.html |
"ROR" |
https://ror.org/02pc6pc55 |
Funders
Funder type
Government
Ministry of Health, Labor and Welfare (Japan) (ref: H19- Trans- General-005)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
21/08/2019: Publication reference and total final enrolment added.
