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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002224
Receipt No. R000002682
Scientific Title Immediate cooling of the brain during the resuscitation period by the use of a pharyngeal cooling device
Date of disclosure of the study information 2009/07/31
Last modified on 2014/02/19

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Basic information
Public title Immediate cooling of the brain during the resuscitation period by the use of a pharyngeal cooling device
Acronym i-Cool
Scientific Title Immediate cooling of the brain during the resuscitation period by the use of a pharyngeal cooling device
Scientific Title:Acronym i-Cool
Region
Japan

Condition
Condition Witnessed cardiac arrest(except cardiac arrest due to trauma)
Classification by specialty
Cardiology Neurology Anesthesiology
Neurosurgery Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Time until tympanic temperature decreases by 1.0 degrees centigrade.
Glasgow Coma Scale at 2 weeks after resuscitation
Glasgow Pittsburgh cerebral performance and overall performance categories at 1 month and 6 months after resuscitation
Mortality rates at 1 month and 6 months after resuscitation
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Patients in the treatment group will undergo 2 hours of pharyngeal cooling during resuscitation or early after recovery of spontaneous circulation.
Interventions/Control_2 Patients in the control group will not undergo pharyngeal cooling during or after resuscitation.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
16 years-old <=
Age-upper limit
89 years-old >=
Gender Male and Female
Key inclusion criteria 1. Patients with witnessed cardiogenic cardiac arrest or witnessed non-cardiogenic cardiac arrest except posttraumatic cardiac arrest.
2. Patients who have been resuscitated by medical services within 15 min after the onset of cardiac arrest.
Key exclusion criteria 1. Patients with a disorder in the pharynx or esophagus.
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.
5. Patients with brain damage initiated by a mechanism other than cardiac arrest.
6. Rejection by a person in parental authority.
7. Score of Barthel index of less than 66.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyoshi Morita, MD, PhD
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science
Division name Functional Physiology
Zip code
Address 2-5-1 Shikata-cho Okayama
TEL 81-86-235-7778
Email yoshit@cc.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshimasa Takeda, MD, PhD
Organization Okayama University Medical School
Division name Anesthesiology & Resuscitology
Zip code
Address 2-5-1 Shikata-cho Okayama
TEL 81-86-235-7778
Homepage URL http://www.cc.okayama-u.ac.jp/~cool/index.html
Email yoshit@cc.okayama-u.ac.jp

Sponsor
Institute Okayama University Medical School
Institute
Department

Funding Source
Organization Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2009 Year 07 Month 31 Day

Related information
URL releasing protocol http://www.cc.okayama-u.ac.jp/~cool/protocol.html
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2009 Year 01 Month 25 Day
Date of IRB
Anticipated trial start date
2009 Year 06 Month 01 Day
Last follow-up date
2011 Year 11 Month 30 Day
Date of closure to data entry
2011 Year 11 Month 30 Day
Date trial data considered complete
2011 Year 11 Month 30 Day
Date analysis concluded
2012 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 07 Month 18 Day
Last modified on
2014 Year 02 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002682

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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