UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044667 |
|---|---|
| Receipt number | R000051011 |
| Scientific Title | A study of changes in emergency department cardiopulmonary resuscitation during the COVID-19 pandemic |
| Date of disclosure of the study information | 2021/08/01 |
| Last modified on | 2022/01/11 00:16:41 |
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Basic information
Public title
A study of changes in emergency department cardiopulmonary resuscitation during the COVID-19 pandemic
Acronym
A study of changes in emergency department cardiopulmonary resuscitation during the COVID-19 pandemic
Scientific Title
A study of changes in emergency department cardiopulmonary resuscitation during the COVID-19 pandemic
Scientific Title:Acronym
A study of changes in emergency department cardiopulmonary resuscitation during the COVID-19 pandemic
Region
| Japan |
Condition
Condition
Cardiopulmonary arrest on arrival
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the impact of COVID-19 pandemic on cardiopulmonary resuscitation in our emergency department.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of survival hospitalization and discharge rates for secondary cardiopulmonary resuscitation performed in the year of the outbreak and the year of the target outbreak of novel coronavirus infection
Key secondary outcomes
Comparison of the background of secondary cardiopulmonary resuscitation performed between the year of the novel coronavirus outbreak and the target year
Comparison of the elapsed time of secondary cardiopulmonary resuscitation performed between the year of the outbreak and the target year of the novel coronavirus infection
Time to hospital transport in emergency patients
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 who visit our emergency room and meet all of the following criteria will be eligible.
1) Year of COVID-19 pandemic
Patients with cardiopulmonary arrest at the time of admission who were transported to the emergency room between January 1, 2020 and March 31, 2021.
2) Comparison group
January 1, 2015 to December 31, 2019
Cardiopulmonary arrest at the time of arrival at the hospital who were transported to the emergency room during the above period.
Key exclusion criteria
Cases in which consent was not obtained
Target sample size
1230
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Yamagami |
Organization
Shonan Kamakura General Hospital
Division name
Department of Emergency Medicine
Zip code
247-0072
Address
1370-1 Okamoto, Kamakura city, Kanagawa
TEL
0467-46-1717
defender8chan@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Ichiro |
| Middle name | |
| Last name | Sekine |
Organization
Shonan Kamakura General Hospital
Division name
Department of Emergency Medicine
Zip code
247-0072
Address
1370-1 Okamoto, Kamakura city, Kanagawa
TEL
0467-46-1717
Homepage URL
ichirosekine@yahoo.co.jp
Sponsor or person
Institute
Shonan Kamakura General Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Tokushukai Group Ethics Committee
Address
Emina Building 3F, 1-8-7, Koji-machi, Chiyoda-ku, Tokyo, Japan
Tel
03-3263-4801
mirai-ec1@mirai-iryo.com
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
| 2021 | Year | 08 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Register the relevant patients as research subjects and obtain the following clinical information from the medical records at the time of registration.
Background of the research subject: gender, date of birth, identification code of the research subject, height, weight
Time of resuscitation: time of admission to the hospital, time of cessation of resuscitation, time of resumption of autologous heartbeat, and time of death confirmation
Information on cardiopulmonary arrest: initial waveform, waveform at the time of admission to the hospital, presence or absence of cardiopulmonary arrest, presence or absence of bystander CPR, presence or absence of tracheal intubation, medications administered, presence or absence of defibrillation
History of cardiopulmonary arrest
Management information
Registered date
| 2021 | Year | 06 | Month | 26 | Day |
Last modified on
| 2022 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051011
