UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006954 |
|---|---|
| Receipt number | R000008144 |
| Scientific Title | Mechanical External Compression for Human Cardiac Arrest -Nonrandomized non-Interventional Comparison Study- |
| Date of disclosure of the study information | 2011/12/27 |
| Last modified on | 2014/12/26 09:33:01 |
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Basic information
Public title
Mechanical External Compression for Human Cardiac Arrest
-Nonrandomized non-Interventional Comparison Study-
Acronym
MECHANICS
Scientific Title
Mechanical External Compression for Human Cardiac Arrest
-Nonrandomized non-Interventional Comparison Study-
Scientific Title:Acronym
MECHANICS
Region
| Japan |
Condition
Condition
out-of-hospital cardiopulmonary arrest
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to verify the efficacy of cardiopulmonary resuscitation using automatic chest compressors for patients with out-of-hospital cardiac arrest (OHCA) in a non-randomized prospective observational fashion.The objective of this study is to verify the efficacy of cardiopulmonary resuscitation using automatic chest compressors for patients with out-of-hospital cardiac arrest (OHCA) in a non-randomized prospective observational fashion.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The ratio of return of spontaneous circulation (ROSC) before hospital arrival shall be the primary outcome measure.
Key secondary outcomes
Survival at 1 month and survival at 1 month with minimal neurologic impairment, which was defined as Glasgow-Pittsburgh Cerebral Performance Category 1 (good cerebral performance) or 2 (moderate cerebral disability) shall be secondary outcome measures.
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
| 18 | years-old | <= |
Age-upper limit
| 76 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Patients who were experiencing cardiac arrest at the time of contact by ambulance team
(2) Patients who underwent cardiopulmonary resuscitation by ambulance team
(3) Patients not younger than 18 years and younger than 76 years
(4) Patients in whom the first identified ECG waveform suggested pulseless electrical activity (PEA)
*Regardless of existence or nonexistence of witness, regardless of with or without bystander cardiopulmonary resuscitation (CPR), and regardless of particulars of support by the ambulance team.
(5) Patients judged to suffer endogenous OHCA at the medical organization to which the patient has been transferred
(6) Patients for whom the ambulance team acted in an attempt to begin using an automatic chest compressor as soon as possible after confirming an initial ECG waveform (implementation within 3 minutes is desirable).
* It does not matter whether use of the automatic chest compressor was started actually within 3 minutes.
Key exclusion criteria
(1) Patients who underwent electric shock by a layperson using an AED
Target sample size
1590
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya Sakamoto |
Organization
Teikyo University School of Medicine
Division name
Department of Emergency Medicine
Zip code
Address
2-11-1 Kaga, Itabashi, Tokyo,Japan
TEL
03-3964-1211
tseizan@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuo Takeuchi |
Organization
Teikyo University
Division name
Institute of Global Education
Zip code
Address
2-11-1 Kaga, Itabashi, Tokyo,Japan
TEL
03-3964-1211
Homepage URL
ytake@med.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University School of Medicine, Department of Emergency Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour 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
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
| 2011 | Year | 12 | Month | 27 | 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
| 2011 | Year | 12 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 11 | Month | 22 | Day |
Date of closure to data entry
| 2013 | Year | 11 | Month | 22 | Day |
Date trial data considered complete
| 2013 | Year | 11 | Month | 22 | Day |
Date analysis concluded
| 2013 | Year | 11 | Month | 22 | Day |
Other
Other related information
prospective cohort with historical control
Management information
Registered date
| 2011 | Year | 12 | Month | 26 | Day |
Last modified on
| 2014 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008144
