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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022137
Receipt No. R000025510
Scientific Title The Effectiveness of the device to recognize cardiac arrests: a validation study
Date of disclosure of the study information 2016/05/01
Last modified on 2018/03/19

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Basic information
Public title The Effectiveness of the device to recognize cardiac arrests: a validation study
Acronym Life saving supporter trial
Scientific Title The Effectiveness of the device to recognize cardiac arrests: a validation study
Scientific Title:Acronym Life saving supporter trial
Region
Japan

Condition
Condition Out-of-hospital cardiac arrests
Classification by specialty
Cardiology Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate sensitivity and specificity based on new algorithm for recognizing cardiac arrests
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Diagnostic accuracy of cardiac arrests
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with out-of-hospital cardiac arrests who received cardiopulmonary resuscitation by emergency medical services personnel
Key exclusion criteria 1. Severe trauma on patients' forehead
2. Severe sweat on patients' forehead
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Taku Iwami
Organization Kyoto University
Division name Health Services
Zip code
Address Yoshida-honmachi, Sakyo-ku, Kyoto, Japan. 606-8501
TEL 075-753-2426
Email iwami.taku.8w@kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshihiro Hatakeyama
Organization Kyoto University
Division name Department of Preventive Services
Zip code
Address Yoshida-honmachi, Sakyo-ku, Kyoto, Japan. 606-8501
TEL 075-753-2431
Homepage URL
Email toshihiro792003@yahoo.co.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization NIHON KOHDEN CORPORATION
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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
2016 Year 05 Month 01 Day

Related information
URL releasing protocol
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
2016 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1. Diagnosis of cardiac arrests by new algorithm for recognizing cardiac arrests or emergency medical services personnel
2. Patients' age
3. Patients' sex
4. Patients' blood pressure
5. Administering of adrenaline
6. The etiology of cardiac arrests

Management information
Registered date
2016 Year 04 Month 29 Day
Last modified on
2018 Year 03 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025510

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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