Condition category
Surgery
Date applied
23/11/2009
Date assigned
10/12/2009
Last edited
10/12/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.cc.okayama-u.ac.jp/~cool/index.html

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

Publication citations

Additional files

Editorial Notes