UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047074 |
|---|---|
| Receipt number | R000053703 |
| Scientific Title | Adverse events related to resuscitation with a mechanical chest compression device (MCCD): a prospective observational study |
| Date of disclosure of the study information | 2022/03/04 |
| Last modified on | 2022/09/03 11:26:39 |
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Basic information
Public title
Study of trauma associated with the use of an automatic cardiac massager during cardiopulmonary resuscitation
Acronym
Trauma due to the use of an automatic cardiac massager
Scientific Title
Adverse events related to resuscitation with a mechanical chest compression device (MCCD): a prospective observational study
Scientific Title:Acronym
Adverse events due to mechanical chest compression device (MCCD)
Region
| Japan |
Condition
Condition
Non-traumatic out-of-hospital cardiac arrest
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is conducted to clarify the actual conditions and characteristics about adverse events in the use of LUCAS(Lund University Cardiac Arrest System, Physio Control, USA), one of the widely used MCCDs in Japan, for patients with out-of-hospital cardiac arrest.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
By combining clinical findings and CT image interpretation findings by a radiologist, a) skin damage, b) sternum / rib fracture, c) pneumothorax / hemothorax, d) presence or absence of parenchymal organ damage is evaluated.
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 non-traumatic out-of-hospital cardiac arrest who used LUCAS, a mechanical chest compression device
Key exclusion criteria
None
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Shigeki |
| Middle name | |
| Last name | Kushimoto |
Organization
Tohoku University Graduate School of Medicine
Division name
Emergency and Critical Care Medicine
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan.
TEL
022-717-7489
information@emergency-medicine.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuya |
| Middle name | |
| Last name | Sato |
Organization
Tohoku University Hospital
Division name
Emergency and Critical Care Medicine
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan.
TEL
022-717-7489
Homepage URL
t23jor@med.tohoku.ac.jp
Sponsor or person
Institute
Division of Emergency and Critical Care Medicine, Tohoku University Graduate School of Medicine/ Department of Emergency and Critical Care Medicine, Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Sendai City Hospital Emergency Care Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University Graduate School of Medicine, Independent Ethics Committee
Address
2-1 Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan.
Tel
022-728-4105
med-kenkyo@grp.tohoku.ac.jp
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
| 2022 | Year | 03 | Month | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 02 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Descriptive statistics show adverse events, which are the primary endpoints. We collect clinical information from medical records and LUCAS usage records by emergency services, and analyze these data to search for factors related to the occurrence of each adverse event.
Management information
Registered date
| 2022 | Year | 03 | Month | 04 | Day |
Last modified on
| 2022 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053703
